BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 1234081 · Received November 4, 2008

    Report

    Report Number
    1823260-2008-08141
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 6, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE, BUT NOTED THE USER EXPERIENCED WATER DRIPPING FROM THE SLIPPER PROBE WHICH MAY HAVE BEEN THE CAUSE. HE WAS UNABLE TO DUPLICATE THE ISSUE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPEC.

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT TSH AND FT4 RESULTS FOR ABOUT TWENTY PT SAMPLES. EIGHTEEN EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL TSH 1.14 UIU/ML, REPEAT 5.77 UIU/ML. SAMPLE 2 INITIAL TSH 0.37 UIU/ML, REPEAT 1.33 UIU/ML. SAMPLE 3 INITIAL TSH 0.51 UIU/ML, REPEAT 1.82 UIU/ML. SAMPLE 4 INITIAL TSH 0.67 UIU/ML, REPEAT 2.35 UIU/ML. SAMPLE 5 INITIAL TSH 0.44 UIU/ML, REPEAT 2.71 UIU/ML. SAMPLE 6 INITIAL TSH 0.22 UIU/ML, REPEAT 0.54 UIU/ML; INITIAL FT4 7.34 PMOL/L, REPEAT 1.42 PMOL/L. SAMPLE 7 INITIAL TSH 0.07 UIU/ML, REPEAT 0.03 UIU/ML; INITIAL FT4 7.77 PMOL/L, REPEAT 1.37 PMOL/L. SAMPLE 8 INITIAL TSH 1.58 UIU/ML, REPEAT 3.85 UIU/ML; INITIAL FT4 4.97 PMOL/L, REPEAT 1.56 PMOL/L. SAMPLE 9 INITIAL TSH 0.88 UIU/ML, REPEAT 2.35 UIU/ML; INITIAL FT4 7.66 PMOL/L, REPEAT 1.17 PMOL/L. SAMPLE 10 INITIAL TSH 1.13 UIU/ML, REPEAT 2.99 UIU/ML; INITIAL FT4 6.72 PMOL/L, REPEAT 1.07 PMOL/L. SAMPLE 11 INITIAL TSH 2.86 UIU/ML, REPEAT 8.56 UIU/ML. SAMPLE 12 INITIAL TSH 3.08 UIU/ML, REPEAT 10.60 UIU/ML. SAMPLE 13 INITIAL TSH 0.39 UIU/ML, REPEAT 1.05 UIU/ML; INITIAL FT4 6.97 PMOL/L, REPEAT 1.00 PMOL/L. SAMPLE 14 INITIAL TSH 0.57 UIU/ML, REPEAT 1.70 UIU/ML; INITIAL FT4 4.85 PMOL/L, REPEAT 1.23 PMOL/L. SAMPLE 15 INITIAL TSH 0.35 UIU/ML, REPEAT 1.16 UIU/ML; INITIAL FT4 6.39 PMOL/L, REPEAT 1.16 PMOL/L. SAMPLE 16 INITIAL 0.46 UIU/ML, REPEAT 2.58 UIU/ML; INITIAL FT4 7.68 PMOL/L, REPEAT 1.18 PMOL/L. SAMPLE 17 INITIAL TSH 1.60 UIU/ML, REPEAT 4.28 UIU/ML; INITIAL FT4 3.31 PMOL/L, REPEAT 1.05 PMOL/L. SAMPLE 18 INITIAL TSH 0.56 UIU/ML, REPEAT 1.96 UIU/ML. INITIAL RESULTS WERE REPORTED. IT WAS NOT KNOWN IF PTS WERE ADVERSE AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK