BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1051420 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04200
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTS FOUR PT SAMPLES THAT INITIALLY GAVE ZERO RESULTS FOR BUN, ALB AND BICARBONATE, AND WHEN REPEATED ON ANOTHER ANALYZER GAVE ACCEPTABLE RESULTS. NO FURTHER PT DATA WAS PROVIDED. ERRONEOUS RESULTS WERE NOT REPORTED. ALTHOUGH EXACT ROOT CAUSE WAS NOT IDENTIFIED, THE FIELD SERVICE REP REPLACED SAMPLE PROBE, CELLS, LAMP AND SAMPLE LLD BD. PERFORMANCE TESTS WERE PERFORMED 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