BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1051577 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04140
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE PTS WITH DISCREPANT CALCIUM RESULTS, INITIAL TESTING PERFORMED ON ANOTHER ANALYZER WITH SAME METHODOLOGY. PT 1, INITIAL RESULT 10.4 MG/DL, REPEAT 9.2 MG/DL. PT 2 INITIAL RESULT 8.8 MG/DL, REPEAT 9.9 MG/DL. PT 3 INITIAL RESULT 8.6 MG/DL, REPEAT 9.9 MG/DL. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SVC REP WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPEC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK