BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 22727711 · Received August 6, 2025

    Report

    Report Number
    1823260-2025-02411
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 9, 2025
    Report Date
    August 6, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 834094. THE EXPIRATION DATE WAS NOT PROVIDED. THE CALIBRATION AND QC WERE ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. IT WAS NOTED THAT THE CENTRIFUGATION TIME WAS SHORT. THE FIELD SERVICE REPRESENTATIVE FOUND THE ISSUE WAS DUE TO A POOR VACUUM TO THE RINSE ARM. HE REPLACED THE CHECK VALVE, BLEACHED THE RINSE ARM, VACUUM BOTTLES, AND THE VACUUM TANK FLOW PATH. HE PERFORMED TESTS AND CHECKS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE RESULTS FOR MULTIPLE PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE. ONE EXAMPLE WAS PROVIDED. THE INITIAL RESULT WAS 167 U/L. THE REPEATED RESULT WAS 232 U/L. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE CUSTOMER EXPERIENCED A HARDWARE ISSUE AND REPEATED SAMPLES FOR VERIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765900 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown