FDA Device

RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.

Hazard

Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.

What You Should Do

Remedy

Urgent Medical Device Correction Notice 22-001 was issued March 09, 2022 via email. The software issue was resolved with the cloud-based software update to version 2.5.5 on February 24, 2022. No further action required. Customers to submit notification acknowledgement. Contact your Roche Account Manager or contact Accu-Chek Customer Care at 1-800-628-3346 with questions.

Products

RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.
Brand
Roche Diabetes Care, Inc.
UPC
Date of manufacture: 2021-11

Units Affected

81 registered accounts