BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 20777480 · Received November 26, 2024

    Report

    Report Number
    1823260-2024-03422
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 29, 2024
    Report Date
    November 25, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 823649 WITH AN EXPIRATION DATE OF 30-SEP-2025. THE (B)(6) 2024 CALIBRATION AND QC WERE ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE ALARM TRACE SHOWED A CALIBRATION ERROR ALARM ON THE DAY OF THE EVENT. THE FIELD SERVICE REPRESENTATIVE CHECKED THE INSTRUMENT. HE FOUND LOW PRESSURE IN THE GEAR PUMP HEAD AND PERFORMED ADJUSTMENTS. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE URIC ACID VER.2 RESULTS FOR 4 PATIENT SAMPLES ON A COBAS 8000 C 702 MODULE. PATIENT 1: THE INITIAL RESULT WAS 0.05 MG/DL AND THE REPEATED RESULT WAS 4.18 MG/DL. PATIENT 2: THE INITIAL RESULT WAS 0.25 MG/DL AND THE REPEATED RESULT WAS 2.57 MG/DL. ON 12-NOV-2024 IT WAS REPORTED THAT 2 ADDITIONAL PATIENT SAMPLES HAD QUESTIONABLE RESULTS AFTER THE INITIAL SERVICE VISIT. THE DATES THE SAMPLES WERE TESTED WERE NOT PROVIDED. PATIENT 3: THE INITIAL RESULT WAS 0.02 MG/DL AND THE REPEATED RESULT WAS 1.72 MG/DL. PATIENT 4: THE INITIAL RESULT WAS 1.32 MG/DL AND THE REPEATED RESULT WAS 6.64 MG/DL. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630217 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown