BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1133561 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06370
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    June 9, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER FAILED OUT HIGH ON THREE EXTERNAL PROFICIENCY SURVEY SAMPLES FOR VANCOMYCIN, AND RECEIVED DISCREPANT RESULTS UPON REPEAT TESTING. SURVEY SAMPLES #2 AND #4 WERE REPEATED FOUR TIMES; #1 & #3 REPEATED FIVE TIMES AND #5 REPEATED 6 TIMES, IN 2008. SURVEY #1, INITIAL RESULT GAVE 47.10 UG/ML, REPEATS GAVE 36.1, 34.5, 30.0, 32.0 AND 30.8 UG/ML. SURVEY #2, INITIAL RESULT GAVE 10.6 UG/ML, REPEATS GAVE 8.2, 7.3, 7.3 AND 6.4 UG/ML. SURVEY #3, INITIAL RESULT GAVE 35.30 UG/ML, REPEATS GAVE 28.0, 28.1, 23.9, 25.3 AND 24.4 UG/ML. SURVEY #4, INITIAL RESULT GAVE 14.90 UG/ML, REPEATS GAVE 14.0, 11.8, 11.0 AND 10.3 UG/ML. SURVEY #5, INITIAL RESULT GAVE 59.40 UG/ML, REPEATS GAVE 46.7, 44.7, 41.4, 38.3, 41.7 AND 42.5 UG/ML. NO PATIENT SAMPLES WERE IMPACTED IN THIS EVENT. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK