navify POC Operations 10170280001Recalls & reported problems
Roche Diagnostics GmbH · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336228623), received between Nov 18, 2025 and Nov 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Transmit Record” (2 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Transmit Record2
- Computer Software Problem1
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Failure to Transmit Record; Missing Information; Failure to Transmit Record; Missing Information
THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH NAVIFY POC OPERATIONS SOFTWARE. THE SOFTWARE IS NOT APPLYING A FLAG PATIENT RESULTS. THE DATA IS NOT BEING FLAGGED AS "QCE" INDICATING A QUALITY CONTROL ERROR, DESPITE BEING FLAGGED AS SUCH IN THE SOFTWARE DATASPHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584593 ↗MalfunctionNov 18, 2025Computer Software Problem; Failure to Transmit Record; Computer Software Problem; Failure to Transmit Record
THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH THE NAVIFY POC OPERATIONS SOFTWARE. THE CUSTOMER WAS USING A COBAS PULSE INSTRUMENT AND IT IS CONFIGURED TO DISABLE PATIENT COMMENTS. MEASUREMENTS FROM THE INSTRUMENT, HOWEVER, ARE SHOWING UP WITH THE FLAG "MRF:A" IN THE RESULT DETAIL PART OF THE NAVIFY SOFTWARE AS AN OPERATOR COMMENT. THIS FLAG MAY POTENTIALLY CAUSE A RESULT MISINTERPRETATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584353 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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