Drug Safety Alerts

Accu-Chek Urgent Medical Device Correction

7/28/2021

On July 28, 2021, Roche issued an Urgent Medical Device Correction relating to Accu-Chek® Aviva-Plus and Accu-Chek® SmartView Test Strips. This Urgent Medical Device Correction was issued because of complaints about test strip vials opening while still inside a sealed carton during shipment. An open vial might expose the test strips to humidity, which might damage the strips and could result in inaccurate results (such as positively biased or falsely too high results).

A complete list of affected products can be found here.

Inappropriate therapy decisions based on inaccurate results could lead to adverse health consequences. This could happen to Accu-Chek Aviva Plus and Accu-Chek SmartView test strips when they are shipped at elevated temperatures (≥45°C or 113°F) and when the carton is dropped or handled roughly during transit and the distribution process. It is only when these two conditions occur in combination that the failure mode has been observed.

This could be a health hazard or safety risk to patients using product affected by this urgent medical device correction.

Consumers who have a test strip vial that has opened while still in a sealed carton may not be able to perform a valid blood glucose measurement on their meter, because an open vial may expose the test strips to humidity which damages the strips. This could lead to inaccurate results (such as positively biased, or falsely too high, results). Inappropriate therapy decisions based on inaccurate results could lead to adverse health consequences.

According to Roche, investigations have revealed that, in rare circumstances, it is possible that a vial can open in a sealed carton while in transit. This could happen to Accu-Chek® Aviva-Plus and Accu-Chek® SmartView Test Strips when they are shipped at elevated temperatures (≥45°C or 113°F) and when the carton is dropped or handled roughly during transit and the distribution process. It is only when these two conditions occur in combination that the failure mode has been observed.

Roche recommends that patients should check vials of Accu-Chek® Aviva-Plus and Accu-Chek® SmartView Test Strips before use and DO NOT use the test strips if:

• The 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.

• Anything prevents the cap from closing properly.

• DO NOT perform control testing if you open a sealed carton and any of the vials inside meet the criteria listed above.

For further information on this issue, please see the full Urgent Medical Device Correction notice at https://www.accu-chek.com/sites/g/files/iut341/f/umdc_21-001_final_0.pdf.

CVS Caremark® Response: CVS Caremark® Mail Service Pharmacy will continue to dispense these products.

For more information about the urgent medical device correction, please call Accu-Chek Customer Care toll-free at 1-866-805-5919. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.