Agency classClass IIOur severity:High FDA (Devices)·Z-1008-2022·Announced 2022-05-04

Diabetes Management Software May Display Wrong Patient Data

Roche Diabetes Care Platform Software version 2.5.2 may display incorrect patient data when users navigate between patient records using the browser back button. No illnesses have been reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device software with potential to display incorrect patient data, representing a risk-of-harm product. No illnesses or injuries have been reported, placing it in the High severity category per the rubric.

Plain-English summary

Roche Diabetes Care, Inc. has recalled Roche Diabetes Care Platform Software version 2.5.2 (material number 08888353001) due to a potential for patient data mismatch. The issue occurs when users navigate between patient records using the browser "back" button. This navigation method can result in the software displaying data from a previously viewed patient while associating it with a different patient record.

The recall affects 81 registered accounts across the United States, including sites in Alaska, Arizona, California, Colorado, the District of Columbia, Florida, Georgia, Illinois, Indiana, Minnesota, North Carolina, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Texas, and Wisconsin. The affected software version was manufactured in November 2021.

No illnesses or injuries have been reported in connection with this issue.

The recalled product

Product: 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.
Manufacturer: Roche Diabetes Care, Inc.
Category: Medical Device — Diabetes Management Software
Hazard: patient-data-mismatch
Affected units: 81

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Date of manufacture: 2021-11

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Same manufacturer · Roche Diabetes Care, Inc.

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