BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1193402 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07439
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED MULTIPLE DISCREPANT CALCIUM RESULTS DURING OVERNIGHT SHIFT. EXACT NUMBER OF PT SAMPLES IMPACTED NOT PROVIDED. TWO PT EXAMPLES WERE PROVIDED. PT 1, INITIAL RESULT 8.9 MG/DL, REPEAT 10.3 MG/DL. PT 2, INITIAL RESULT 9.1 MG/DL, REPEAT 10.0 MG/DL. NO ERRONEOUS RESULTS WERE REPORTED. CUSTOMER REFUSED TO PROVIDE ANY ADDITIONAL PT INFO. THE FIELD SERVICE REPRESENTATIVE DETERMINED FAULTY VALVES TO BE THE CAUSE AND ON SUBSEQUENT VISIT REPLACED VALVES SV16 AND SV18. 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