BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1232552 · Received November 13, 2008

    Report

    Report Number
    1823260-2008-08370
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED LOW SODIUM AND CALCIUM RESULTS FOR APPROX. 80 PATIENT SAMPLES. THE FOLLOWING 38 EXAMPLES FOR SODIUM WERE PROVIDED. ALL RESULTS IN MMOL/L. RESULTS ARE INITIAL/REPEAT. SAMPLE 1 129/136, SAMPLE 2 128/135, SAMPLE 3 123/129, SAMPLE 4 27/134, SAMPLE 5 129/135, SAMPLE 6 127/135, SAMPLE 7 132/139, SAMPLE 8 129/138, SAMPLE 9 129/135, SAMPLE 10 131/137, SAMPLE 11 130/137, SAMPLE 12 132/141, SAMPLE 13 1 132/141, SAMPLE 14 130/138, SAMPLE 15 131/140, SAMPLE 16 129/137, SAMPLE 17 132/141, SAMPLE 18 131/140, SAMPLE 19 133/142, SAMPLE 20 130/138, SAMPLE 21 133/142, SAMPLE 22 129/135, SAMPLE 23 138/135, SAMPLE 24 127/134, SAMPLE 25 123/129, SAMPLE 26 128/135, SAMPLE 27 129/136, SAMPLE 28 128/135, SAMPLE 29 130/136, SAMPLE 30 131/137, SAMPLE 31 126/133, SAMPLE 32 127/133, SAMPLE 33 129/136, SAMPLE 34 132/140, SAMPLE 35 133/141, SAMPLE 36 130/138, SAMPLE 37 134/142, SAMPLE 38 134/143. THE FOLLOWING 68 EXAMPLES FOR CALCIUM WERE PROVIDED. ALL RESULTS IN MG/DL. RESULTS ARE INITIAL/REPEAT. SAMPLE 1 7.0/7.9, SAMPLE 2 7.0/7.8, SAMPLE 3 6.6/7.4, SAMPLE 4 6.6/7.4, SAMPLE 5 7.0/7.8, SAMPLE 6 7.0/7.9, SAMPLE 7 7.7/8.8, SAMPLE 8 8.6/9.8, SAMPLE 9 6.9/7.8, SAMPLE 10 8.2/9.4, SAMPLE 11 7.9/9.1, SAMPLE 12 6.7/7.5, SAMPLE 13 7.1/7.8, SAMPLE 14 8.1/8.9, SAMPLE 15 6.8/7.5, SAMPLE 16 6.8/7.5, SAMPLE 17 8.1/9.1, SAMPLE 18 7.9/8.8, SAMPLE 19 7.9/8.9, SAMPLE 20 7.3/8.1, SAMPLE 21 7.7/8.8, SAMPLE 22 8.5/9.3, SAMPLE 23 8.8/9.9, SAMPLE 24 7.9/8.7, SAMPLE 25 7.9/8.9, SAMPLE 26 7.6/8.6, SAMPLE 27 7.0/7.8, SAMPLE 28 7.0/7.8, SAMPLE 29 7.6/8.6, SAMPLE 30 8.9/10.0, SAMPLE 31 8.3/9.2, SAMPLE 32 7.5/8.5, SAMPLE 33 8.8/10.1, SAMPLE 34 8.2/9.2, SAMPLE 35 7.9/8.9, SAMPLE 36 8.7/9.8, SAMPLE 37 7.7/8.6, SAMPLE 38 7.0/7.7, SAMPLE 39 6.6/7.4, SAMPLE 40 7.8/9.0, SAMPLE 41 7.6/8.4, SAMPLE 42 7.8/8.9, SAMPLE 43 7.9/9.0, SAMPLE 44 9.0/10.4, SAMPLE 45 7.6/8.6, SAMPLE 46 7.4/8.2, SAMPLE 47 8.2/9.1, SAMPLE 48 7.4/8.4, SAMPLE 49 7.6/8.6, SAMPLE 50 9.2/10.1, SAMPLE 51 8.6/9.8, SAMPLE 52 7.4/8.4, SAMPLE 53 7.0/8.1, SAMPLE 54 8.3/9.4, SAMPLE 55 7.3/8.4, SAMPLE 56 7.6/8.6, SAMPLE 57 7.2/8.1, SAMPLE 58 7.7/8.8, SAMPLE 59 7.7/8.8, SAMPLE 60 7.7/8.6, SAMPLE 61 8.2/9.4, SAMPLE 62 7.2/8.3, SAMPLE 63 7.2/8.1, SAMPLE 64 7.9/9.0, SAMPLE 65 7.6/8.7, SAMPLE 66 7.0/7.9, SAMPLE 67 7.6/8.4, SAMPLE 68 8.7/9.6. ALL INITIAL RESULTS WERE REPORTED. NO INFO FROM THE USER WAS PROVIDED AS TO THE TREATMENT OF THE PATIENTS AS A RESULT OF THE ERRONEOUS RESULTS REPORTED. THE FIELD SERVICE REP STATED THE USER HAD FOUND THEY NEEDED TO RERUN CALIBRATION ON CALCIUM AND THE ISE SOLUTIONS NEEDED TO BE CHANGED. RECALIBRATION IMPROVED PERFORMANCE OF THE ASSAY.

    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