BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1133406 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06362
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 3, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCED 12 TO 15 PATIENT SAMPLES WITH QUESTIONABLE RESULTS. ONLY THE FOLLOWING TWO EXAMPLES WERE PROVIDED. EXAMPLE 1, INITIAL CALCIUM GAVE .2 MG/DL; REPEAT GAVE 7.4 MG/DL. EXAMPLE 2, INITIAL PHOSPHORUS GAVE 1.1 MG/DL; REPEAT GAVE 15 MG/DL. THE RESULTS WERE NOT RELEASED OR TURNED OUT. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE WORN Z-ROPES ON THE TRANSFER 2 MECHANISM, AND REPLACED THE Z-ROPES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK