BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 20589910 · Received November 1, 2024

    Report

    Report Number
    1823260-2024-03167
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    October 17, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 823927. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND A BLOCKAGE IN A RINSE UNIT TUBE AND RESOLVED THE ISSUE. THE ANALYZER ALARM TRACE CONTAINED ASPIRATION ERRORS, WHICH CAN BE AN INDICATOR OF POOR PREANALYTICS. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE (CREP) GEN.2 RESULTS FROM THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 4.20 MG/DL AND THE REPEAT RESULT WAS 0.66 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775052 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown