BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 24802182 · Received April 7, 2026

    Report

    Report Number
    1823260-2026-01322
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 7, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    UDI-DI
    04015630925131
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UREA/BUN REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS 8000 C702 MODULE SERIAL NUMBER IS (B)(6). THE CUSTOMER ALSO REPORTED CALIBRATION FAILURES. THE FIELD SERVICE ENGINEER PERFORMED A SERIES OF TROUBLESHOOTING-RELATED ACTIONS, INCLUDING VERIFYING THE GEAR PUMP HEAD, THE VACUUM PUMP READING, THE RINSE NOZZLE CONDITION, AND FLUSHING THE RINSE NOZZLE AND THE PROBES. HE FOUND THAT THE RINSE WATER LEVEL IN THE CELL RINSE STATION WAS LOWER THAN SPECIFIED. HE ADJUSTED THE RINSE WATER LEVEL IN THE CELL RINSE STATION AND PERFORMED CALIBRATION AND QC, AND THEY WERE WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH THE UREA/BUN ASSAY ON A COBAS 8000 C702 MODULE. INITIAL RESULT: 3.7 MMOL/L. AFTER REVIEWING THE PATIENT'S HISTORY, THE SAMPLE WAS REPEATED ON ANOTHER LINE. REPEAT RESULT: 24.42 MMOL/L. THE RESULT OF 20+ MMOL/L WAS DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265096 UREA/BUN UREA NITROGEN TEST SYSTEM CDQ ROCHE DIAGNOSTICS 924957 04015630925131

    Patients

    Seq Age Sex Outcome Treatment
    1