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.
What this means for you
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.
- Hazard
- patient-data-mismatch
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.
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