Accu-Chek Aviva, Accu-Chek Performa

Urgent field safety notice

Internal

May 2018

Important information on selected lots of Accu-Chek® Aviva (50s, 10s) and Accu-Chek® Performa (10s) strips potentially showing an increased number of strip errors prior to dosing or biased results

Dear Healthcare Professional, At Roche Diabetes Care we hold our products to the highest standards of quality and are committed to communicating any issues impacting the operation of our products. This is why we would like to inform you today about an issue that might occur in certain lots of the Accu-Chek Aviva and Accu-Chek Performa test strips. As part of our ongoing quality monitoring and market surveillance processes, we have identified certain test strip lots that potentially show an increase in strip errors prior to dosing. Due to the designed fail-safe in the blood glucose meter, the issue can be identified by an error message displayed on the meter upon strip insertion or through the device not recognising the test strip. However, in a very limited number of cases the test strip can produce a biased result i.e. a falsely too high or too low value, which your patients might not be able to detect easily and which could lead to erroneous therapy adaptations. The affected UK products are: Accu-Chek Aviva 50s Accu-Chek Aviva 10s (Sold in retail only) Accu-Chek Performa 10s (Sold in retail only) Accu-Chek Performa 10s contained with Accu-Chek Performa Nano meter kits As patient safety is our first priority, we would therefore like to ask you to advise your patients to:

• check the lot numbers of their test strip supplies against the complete list of lot numbers in Appendix A. You can also do this online by visiting www.accu-chek.co.uk/customer-service/field-safety-notices. They can find the lot number on the top flap of the vial carton packaging as well as on the label of each test strip vial as shown in the picture below.

Consumer Letter

(Accu-Chek Aviva, Accu-Chek Performa)

Urgent field safety notice

May, 2018

Important information on selected lots of Accu-Chek® Aviva and Accu-Chek Performa test strips potentially showing an increased number of strip errors prior to dosing or biased results

Dear Customer, At Roche Diabetes Care we hold our products to the highest standards of quality and are committed to communicating any issues impacting the operation of our products. This is why we would like to inform you today about an issue that might occur in certain lots of the Accu-Chek Aviva , Accu-Chek Performa test strips, and Accu-Chek Performa strips that have been included in Accu-Chek Performa Nano meter kits. As part of our ongoing quality monitoring and market surveillance processes, we have identified certain test strip lots that potentially show an increase in strip errors prior to dosing. Due to the designed fail-safe in the blood glucose meter, the issue can be identified by an error message displayed on the meter upon strip insertion or through the device not recognising the test strip. However, in a very limited number of cases the test strip can produce a biased result i.e. a falsely too high or too low value, which you might not be able to detect easily and which could lead to incorrect therapy adaptations. As patient safety is our first priority, we would therefore like to ask you to: • Check the lot numbers of your test strip supplies against the complete list of lot numbers in

Appendix A.

• You can find the lot number on the top flap of the vial carton packaging as well as on the label of each test strip vial as shown in the picture below.

• discontinue using strips from the affected lots immediately and please return to the pharmacy or store where you obtained the strips for a replacement pack

• Please complete the attached acknowledgement form and return it via freepost within 7 days of receipt of this notification

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If your test strip supply is not from the affected lots, you can continue using these test strips and no additional action is required.

We have thoroughly investigated this issue to identify the root cause of this potential error and have already started to implement the appropriate corrective measures. Please be assured that this issue only affects specific lots of the Accu-Chek Aviva and Accu-Chek Performa test strips. Other Accu-Chek blood glucose test strips available in your market are not impacted by this issue. The MHRA, users of the affected blood glucose monitoring systems, healthcare professionals, hospitals, distributors and retailers will all be informed about this field action. If you need any additional advice on the operation of your Accu-Chek blood glucose meter and test strips or have any further questions or concerns, please call our Accu-Chek Customer Careline on 0800 701 000 or visit the www.accu-chek.co.uk website. If you are a pump user please contact the Accu-Chek Pump Careline on 0800 731 2291. It is through the careful monitoring of customer reports that we are able to identify issues and implement solutions. We appreciate your time and attention to this important notification. Kind regards, Roche Diabetes Care Appendix A: List of affected lot numbers

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APPENDIX A: LOT NUMBERS UK ACCU-CHEK AVIVA STRIPS (50s)

• 497392 • 497391 • 496915 • 496809 • 496802 • 496807

ACCU-CHEK AVIVA STRIPS (10s)

• 497344 • 497392

ACCU-CHEK PERFORMA STRIPS (10s)

• 476597 • 476646

Accu-Chek Performa Nano mmol Kit. [Please note that the FSN only applies to the pack of Performa 10 test strips contained within the kit]

• 10153116 • 10153114 • 10153115 • 10153112 • 10153111

Pharmacy Letter

(Accu-Chek Aviva, Accu-Chek

Performa)

Urgent field safety notice

May, 2018

Important information on selected lots of Accu-Chek® Aviva and Accu-Chek Performa test

strips potentially showing an increased number of strip errors prior to dosing or biased results

Dear Pharmacy,

At Roche Diabetes Care we hold our products to the highest standards of quality and are committed to

communicating any issues impacting the operation of our products. This is why we would like to inform

you today about an issue that might occur in certain lots of the Accu-Chek Aviva test strips, Accu-Chek

Performa test strips, and Accu-Chek Performa strips that have been included in Accu-Chek Performa

Nano meter kits.

As part of our ongoing quality monitoring and market surveillance processes, we have identified certain

test strip lots that potentially show an increase in strip errors prior to dosing. Due to the designed fail-safe

in the blood glucose meter, the issue can be identified by an error message displayed on the meter upon

strip insertion or through the device not recognising the test strip. However, in a very limited number of

cases the test strip can produce a biased result i.e. a falsely too high or too low value, which you might

not be able to detect easily and which could lead to incorrect therapy adaptations.

As patient safety is our first priority, we would therefore like to ask you to:

• Check the lot numbers of your test strip stock in your pharmacy against the complete list of lot

numbers in appendix A.

• You can find the lot number on the top flap of the vial carton packaging as well as on the label of

each test strip vial as shown in the picture below.

• Discontinue dispensing/selling strips from the affected lots immediately

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• Accept any product from the affected lots that that is returned by a patient/customer and issue a

replacement from another lot.

• Return all affected product to your wholesaler

We have thoroughly investigated this issue to identify the root cause of this potential error and have al-

ready started to implement the appropriate corrective measures. Please be assured that this issue only

affects the Accu-Chek Aviva and Accu-Chek Performa test strips, as well as strips contained within the

Accu-Chek Performa Nano kits in the United Kingdom.

The MHRA, users of the affected blood glucose monitoring systems, healthcare professionals and

hospitals will all be informed about this field action.

Please contact us on 0800 1951440 if you have any further questions or concerns.

Kind regards,

Roche Diabetes Care

Appendix A: List of affected lot numbers

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APPENDIX A: Affected lot numbers UK

ACCU-CHEK AVIVA STRIPS (50s)

PIP CODE: 317-1253

EAN CODE: 4015630008681

• 497392

• 497391

• 496915

• 496809

• 496802

• 496807

ACCU-CHEK AVIVA STRIPS (10s)

PIP CODE: 359-2441

EAN CODE: 4015630008674

• 497344

• 497392

ACCU-CHEK PERFORMA STRIPS (10s)

PIP CODE: 401-9667

EAN CODE: 4015630982653

• 476597

• 476646

Accu-Chek Performa Nano mmol Kit. [Please note that the FSN only applies to the pack of Performa 10

test strips contained within the kit]

EAN CODE: 4015630066339

• 10153116

• 10153114

• 10153115

• 10153112

• 10153111

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• discontinue using strips from the affected lots immediately and please return them to the pharmacy or store where they obtained the strips for a replacement pack at no charge.

Please check for any affected strip lots within your centers:

• Strips within the Accu-Chek Aviva Expert and Accu-Chek Performa Nano meter kits

• Accu-Chek Aviva 50s and 10s

• Accu-Chek Performa 10s

Quarantine any affected lots and notify your local sales representative for collection and to arrange for replacement.

Please select the right option when completing the acknowledgement form and return it on behalf of your practice within 7 days of receipt of this notification.

We have thoroughly investigated this issue to identify the root cause of this potential error and have already started to implement the appropriate corrective measures. Please be assured that this issue only affects specific lots of the Accu-Chek Aviva and Accu-Chek Performa test strips. Other Accu-Chek blood glucose test strips available in your market are not impacted by this issue. The MHRA, users of the affected blood glucose monitoring systems, distributors and retailers will all be informed about this field action. Please call your local sales representative if you need any additional advice on the operation of Accu-Chek blood glucose meters and test strips, or have any further questions or concerns. It is through the careful monitoring of customer reports that we are able to identify issues and implement solutions. We appreciate your time and attention to this important notification. Kind regards, Roche Diabetes Care Appendix A: List of affected lot numbers

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APPENDIX A: AFFECTED LOTS UK ACCU-CHEK AVIVA STRIPS (50s)

• 497392 • 497391 • 496915 • 496809 • 496802 • 496807

ACCU-CHEK AVIVA STRIPS (10s)

• 497344 • 497392

ACCU-CHEK PERFORMA STRIPS (10s)

• 476597 • 476646

Accu-Chek Performa Nano mmol Kit. [Please note that the FSN only applies to the pack of Performa 10 test strips contained within the kit]

• 10153116 • 10153114 • 10153115 • 10153112 • 10153111

*Our records indicate that you may have received stock from these specific affected lots.

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URGENT FIELD SAFETY NOTICE PLEASE COMPLETE AND RETURN BY FAX/E-MAIL

Roche Diabetes Care Reference: SB_RDC_2018_02

Medical Device: Accu-Chek® Aviva and Accu-Chek® Performa test strips

Manufacturer: Roche Diabetes Care

Issue: Important information on selected lots of Accu-Chek® Aviva and Accu-Chek® Performa test strips potentially showing an increased number of strip errors prior to dosing or biased results

Acknowledgement Form / Faxback Please submit this acknowledgement form to Roche Diabetes Care:

via e-mail: burgesshill.dcsafety@roche.com

or postal address:

Local Regulatory and Safety Officer Roche Diabetes Care Ltd Charles Avenue Burgess Hill West Sussex RH15 9RY

I confirm to have received, read and understood the information in this Field Safety Notice of May 2018 for the above mentioned medical devices and intend to perform the requested actions.

Form completed and returned by:

Name (CAPITAL LETTERS):

Position/Title of Person completing this Form:

Company Name:

Phone Number:

E-mail:

Address:

Date (dd-mmm-yyyy):

Signature