BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1022414 · Received March 26, 2008

    Report

    Report Number
    1823260-2008-02762
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE PT SAMPLES WITH DISCREPANT RESULTS COMPARED TO REPEAT TESTING PERFORMED USING A DIFFERENT METHODOLOGY. PT 1. INITIAL CALCIUM GAVE 7.5 MG/DL; REPEAT GAVE 8.6 MG/DL. PT 2. INITIAL CALCIUM GAVE 7.5 MG/DL; REPEAT GAVE 8.5 MG/DL. PT 3. INITIAL PHOSPHOROUS GAVE 10.1 MG/DL; REPEAT GAVE 3.3 MG/DL. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYER - CEM CEM ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK