cobas infinity POC 09159053001Recalls & reported problems
Roche Diagnostics GmbH · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336175385), received between May 16, 2024 and May 16, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Transmit Record” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Transmit Record1
- Program or Algorithm Execution Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2024Failure to Transmit Record; Program or Algorithm Execution Failure; Failure to Transmit Record; Program or Algorithm Execution Failure
THERE WAS AN ALLEGATION OF A RESULT ALARM ISSUE WITH COBAS INFINITY CORE SOFTWARE POC VERSION 2.3.0. IT WAS REPORTED THAT IF A REPORTABLE RANGE FOR COBAS PULSE DEVICES HAVE BEEN CONFIGURED IN THE SOFTWARE, WHEN A PATIENT MEASUREMENT IS SENT FROM THE DEVICE AND HAS A RESULT THAT IS OUTSIDE THE REPORTABLE RANGE, THE RESULT IS SENT TO THE APPLICATION WITH THE ALARM PORH (PATIENT RESULT ABOVE INSTRUMENT REPORTABLE RANGE). HOWEVER, THE RESULT IN THE APPLICATION DOES NOT SHOW THAT ALARM, AND INSTEAD IT DISPLAYS THE ALARM IAR (ALARM FLAG RECEIVED FROM INSTRUMENT). THE REPORTER ALLEGED THAT THE SITUATION WAS ENCOUNTERED DURING AN INTERNAL TEST TO PREPARE TO DEPLOY THIS CONFIGURATION TO CUSTOMER SITES. IT WAS CONFIRMED THAT NO PATIENTS WERE AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19332813 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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