BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H/B-11 MPA 7 PLUS

    MDR report key: 1018586 · Received March 21, 2008

    Report

    Report Number
    1823260-2008-02699
    Event Type
    Malfunction
    Date Received
    March 21, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS EXPERIENCING AN INTERMITTENT ISSUE WITH THEIR MODULAR PRE-ANALYTICS LABORATORY INTEGRATION SYSTEM GENERATING BUBBLES IN SAMPLE CUPS PRIOR TO BEING LOADED ONTO THE ANALYZER FOR TESTING. ACCOUNT STATES THIS ISSUE HAS CAUSED DISCREPANT PT RESULTS FOR APPROXIMATELY 10 PT EXAMPLES STARTING IN 2008. ONLY THE FOLLOWING PT SAMPLE WAS PROVIDED: INITIAL RESULT GAVE 5.9 MG/DL; REPEAT GAVE 9.6 MG/DL. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE PROBLEMS WITH THE ALIQUOT Z DEPTH, ALIQUOT TIP POSITIONING AND TSM SETTINGS. PERFORMED ADJUSTMENTS TO THE ALQ TIP POSITIONING, TIP RACK POSITION, AND SET TSM SETTINGS. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H/B-11 MPA 7 PLUS AUTOMATED PREANALYTICAL SYSTEM JJE ROCHE DIAGNOSTICS MPA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK