BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1061600 · Received June 17, 2008

    Report

    Report Number
    1823260-2008-04772
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    TWO PATIENT SAMPLES WITH DISCREPANT TOTAL BILLIRUBIN RESULTS. PT 1, INITIAL RESULT GAVE 0.3 MG/DL; REPEAT GAVE 10.0 MG/DL. PT 2, INITIAL RESULT GAVE 0.4MG/DL; REPEAT GAVE 11.0 MG/DL. INITIAL RESULTS WERE REPORTED. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE RESULTS. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE DISCREPANCY. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    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