BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 1213181 · Received October 23, 2008

    Report

    Report Number
    1823260-2008-07844
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DAP
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING DISCREPANT D-DIMER RESULTS FOR FIVE PATIENT SAMPLES WHEN RUNNING WITH DECREASED SAMPLE VOLUME. THE FOLLOWING THREE PATIENT EXAMPLES WERE PROVIDED: SAMPLE 1, INITIAL RESULT GAVE 17137 NG/ML, REPEAT GAVE 16830 NG/ML. SAMPLE REPEATED TWICE WITH DECREASED SAMPLE VOLUME GIVING 7294 AND 6714 NG/ML RESPECTIVELY. THE SAMPLE WAS THEN DILUTED GIVING 4777 NG/ML. IN 2008: SAMPLE 2, INITIAL RESULT GAVE 6249 NG/ML; SAMPLE REPEATED THREE TIMES GIVING 6401, 6638 AND WITH DECREASED SAMPLE VOLUME GAVE 16931 NG/ML RESPECTIVELY. SAMPLE 3, INITIAL RESULT GAVE 6681 NG/ML; SAMPLE REPEATED THREE TIMES GIVING 5757, 5811 AND WITH DECREASED SAMPLE VOLUME GAVE 16036 NG/ML RESPECTIVELY. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A PROBLEM WITH THE APPLICATION/SOFTWARE, NOTING INSPECTION OF THE ANALYZER PRESENTED NO PROBLEMS. THE TECHNICAL SERVICE REPRESENTATIVE VERIFIED SYSTEM AND APPLICATION SETTINGS WERE CORRECT. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK