BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1119690 · Received August 12, 2008

    Report

    Report Number
    1823260-2008-06151
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 22, 2008
    Report Date
    August 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING DISCREPANT SODIUM RESULTS ON APPROX 30 PT SAMPLES, EIGHTEEN SPECIFIC RESULTS WERE PROVIDED, SAMPLE 1, INITIAL 131 MMOL/L, REPEAT 137 MMOL/L. SAMPLE 2, INITIAL 129 MMOL/L, REPEAT 139 MMOL/L. SAMPLE 3, INITIAL 123 MMOL/L, REPEAT 130 MMOL/L. SAMPLE 4, INITIAL 124 MMOL/L, REPEAT 134 MMOL/L. SAMPLE 5, INITIAL 133 MMOL/L, REPEAT 142 MMOL/L. SAMPLE 6, INITIAL 128 MMOL/L, REPEAT 137 MMOL/L. SAMPLE 7, INITIAL 132 MMOL/L, REPEAT 141 MMOL/L. SAMPLE 8, INITIAL 129 MMOL/L, REPEAT 138 MMOL/L. SAMPLE 9, INITIAL 131 MMOL/L, REPEAT 141 MMOL/L. SAMPLE 10, INITIAL 130 MMOL/L, REPEAT 140 MMOL/L. SAMPLE 11, INITIAL 131 MMOL/L, REPEAT 140 MMOL/L. SAMPLE 12, INITIAL 131 MMOL/L, REPEAT 139 MMOL/L. SAMPLE 13, INITIAL 129 MMOL/L, REPEAT 138 MMOL/L. SAMPLE 14, INITIAL 129 MMOL/L, REPEAT 138 MMOL/L. SAMPLE 15, INITIAL 127 MMOL/L, REPEAT 137 MMOL/L. SAMPLE 16, INITIAL 129 MMOL/L, REPEAT 138 MMOL/L. SAMPLE 17, INITIAL 128 MMOL/L, REPEAT 138 MMOL/L. SAMPLE 18, INITIAL 131 MMOL/L, REPEAT 140 MMOL/L. ERRONEOUS RESULTS WERE REPORTED. INFO WAS NOT PROVIDED TO DETERMINE IF PTS WERE ADVERSELY AFFECTED . THE FIELD SVC REP DETERMINED THE ISE APPLICATIONS HAD BEEN CALIBRATED WITH AN OLD CALIBRATOR. HE RECALIBRATED THE ASSAY WITH FRESH CALIBRATIONS. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK