BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 21739202 · Received April 1, 2025

    Report

    Report Number
    1823260-2025-00957
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 22, 2025
    Report Date
    April 1, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UA GEN.2 REAGENT LOT NUMBER IS 823649, AND THE EXPIRATION DATE IS SEP-2025. THE UREAL REAGENT LOT NUMBER IS 823651, AND THE EXPIRATION DATE IS MAY-2025. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE RINSING VOLUME WAS LOW DUE TO A PARTIALLY OBSTRUCTED DEGASSER. AFTER REPLACING THE DEGASSER, THE RINSING VOLUME WAS GOOD. DURING THE INSPECTION, THE FSE OBSERVED DRIPPING FROM A RINSING NOZZLE; THE VACUUM TUBE OF THE NOZZLE HAD MICROHOLES, AND IT WAS REPLACED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE UREAL AND UA GEN.2 RESULTS FROM THE COBAS 8000 C702 MODULE. SAMPLE ID: (B)(6) INITIAL URIC ACID RESULT WAS 0.1 MG/DL, AND THE REPEAT RESULT ON ANOTHER C702 WAS 2.9 MG/DL. SAMPLE ID: (B)(6) INITIAL UREA RESULT WAS 2.2 MG/DL, AND THE REPEAT RESULT FROM ANOTHER C702 WAS 49.1 MG/DL. SAMPLE ID: (B)(6) INITIAL UREA RESULT WAS 0.1 MG/DL, AND THE REPEAT RESULT FROM ANOTHER C702 WAS 25.7 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165513 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male