BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1172209 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07047
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED LOW CALCIUM RESULTS FOR SEVERAL PATIENT SAMPLES. SAMPLES WERE THEN REPEATED ON ANOTHER ANALYZER AND RESULTS DID NOT MATCH ORIGINAL RESULTS. EXACT NUMBER OF PATIENT SAMPLES INVOLVED WAS NOT GIVEN. THREE EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT 7.4 MG/DL, REPEAT 8.1 MG/DL. SAMPLE 2 INITIAL RESULT 7.7 MG/DL, REPEAT 8.7 MG/DL. SAMPLE 3 INITIAL RESULT 7.9 MG/DL, REPEAT 9.0 MG/DL. NO CHANGE IN PATIENT TREATMENT AS NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE DI WATER WAS CONTAMINATED AND PERFORMED A DECONTAMINATION OF THE ANALYZER. PERFORMANCE TESTS WERE PERFORMED WHICH ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK