BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS C 502 MODULE

    MDR report key: 24696983 · Received March 26, 2026

    Report

    Report Number
    1823260-2026-01097
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 26, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630928354
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CALIBRATION DATA, THE REAGENT LOT NUMBER IS 873067. THE EXPIRATION DATE WAS NOT PROVIDED. THE CALIBRATION AND QC WERE ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE SAMPLE PROBE WAS CLOGGED. HE REPLACED THE SAMPLE PROBE AND PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 51.73 MG/DL, AND THE REPEATED RESULT WAS 34.89 MG/DL. THE REPEATED RESULT WAS OBTAINED ON ANOTHER MODULE AND WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE CUSTOMER EXPERIENCED ISSUES WITH QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756460 COBAS 8000 COBAS C 502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630928354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown