Important Product Information

Manufacturer Reference: SB_RDC_2023_06 SRN Number: DE-MF-000006276

Oman and Kuwait 2 Nov 2023

Important Information related to the Accu-Chek® Guide system

Situation Description and Rationale for this Corrective Action

We would like to inform you today that a batch of Accu-Chek Guide kits and test strips was mistakenly

shipped to users of this blood glucose meter, wholesalers and pharmacies without the correct language

versions of the relevant instructions for use for Kuwait and Oman.

Users of the Accu-Chek Guide system can easily determine this by looking at the outer packaging and the

instructions for use. Since the meter as well as the test strips function correctly, there is no safety risk

implied for the users.

This problem only affects the material listed below. All other batches were shipped according to

specifications and with the correct language version of the handling instructions.

Details of the Affected Material:

Action taken by Roche Diabetes Care:

We have thoroughly investigated the issue and immediately implemented relevant quality assurance

measures to prevent a re-occurrence of this error.

Recommended Action:

If you have affected test strips in your inventory, please visit our website at any time to refer to the correct

language version of the instructions for use

https://www.rochediabetescaremea.com/en/meter-systems/guide/support

If you are unsure and would like to exchange the affected test strips, please feel free to contact our Roche

Diabetes Care Customer Service for Kuwait at 022069158 – (Sunday to Thursday From 9 AM until 6 PM) and our Roche Diabetes Care Customer Service for Oman at 80074464 ( Sunday to Thursday From 10 AM until 7 PM ) to organize a free-of-charge replacement.

Middle East and Africa July 18, 2021

Important information about open vials of Accu-Chek^® Aviva / Accu-Chek^® Performa test strips

Description of Situation and Rationale giving rise to this corrective measure

Roche Diabetes Care has received complaints from one hospital in the United States alleging unexpected results (such as positively biased, or falsely too high, results) when using test strip vials which have opened while still in a sealed carton.

This could happen to Accu-Chek^® Aviva / Accu-Chek^® Performa test strips, when they are shipped at elevated temperature (≥45°C or 113°F) AND when the carton is dropped or handled roughly during transit and distribution process. It is only when these two conditions occur in combination that the failure mode has been observed.

Due to the influence of high temperature and humidity this failure might affect the accuracy of the blood glucose measurement.

Details on affected test strips

The potentially affected test strips are

• Accu-Chek^® Aviva
• Accu-Chek^® Performa

Actions taken by Roche Diabetes Care

Roche Diabetes Care is updating product labelling to clarify instructions for handling vials that have opened within sealed cartons. Roche Diabetes Care will provide test strip replacements to users who have purchased test strip vials which have opened while still in a sealed carton.

Actions to be taken by the distributors and retailers

Please inform your customers about the below mentioned instructions for users.

Actions to be taken by users of Accu-Chek^® Aviva / Accu-Chek^® Performa test strips

• vial is open or damaged before using the test strips for the first time,    
• the cap is not fully closed
• you see any damage to the cap or vial, or
• Anything prevents the cap from closing properly.

• Please do not perform control testing as instructed in the meter manual.
• If you have any affected product, please refrain from using the concerned test strips.
• Roche Diabetes Care will provide test strip replacements to users who have purchased vials that were open within the sealed carton. To obtain replacement from Roche Diabetes Care, please call our Roche Diabetes Care Customer Care line as shown below:

*For all other countries please visit our support page for local contacts 

Communications of this Field Safety Notice

As our local authorized distributor we would require you to inform your healthcare professionals, customers, retailers and users of the Accu-Chek^® Aviva / Accu-Chek^® Performa test strips about this field action and assure them that this is a rare occurrence and has only been identified in a hospital in the United States.

Additionally, as the local authorized distributor of Roche Diabetes Care products, you are also required to check the local regulations and accordingly inform the relevant national competent authorities, if there is a need to do so. Please also send us a copy of the communication to the authorities for our reference in case we need to support you further with any requests, and for record keeping.

We sincerely apologize for any inconvenience this may cause and hope for your understanding and cooperation. Please inform your customer that users should call our Roche Diabetes Care Customer Care line as mentioned above, if they need any additional advice on the handling of the Accu-Chek^® Aviva / Accu-Chek^® Performa test strips or have any further questions or concerns.

We appreciate your time and attention to this important notification.

Roche Diabetes Care Middle East FZCO

ACCU-CHEK AVIVA is a trademark of Roche.

ACCU-CHEK PERFORMA is a trademark of Roche.