BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS E MODULE CK MB REAGENT

    MDR report key: 1780397 · Received September 14, 2007

    Report

    Report Number
    1823260-2007-08060
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    June 4, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO EXTERNAL QUALITY CONTROL SAMPLES GAVE HIGH CK-MB VALUES AS COMPARED TO EXPECTED VALUES. ON (B)(6) 2007, SAMPLE GAVE VALUE OF 2.1 NG/ML. EXPECTED VALUE OF SAMPLE IF 1.41 NG/ML. ON (B)(6) 2007, A DIFFERENT EXTERNAL QUALITY CONTROL SAMPLE GAVE VALUE OF 3.7 NG/ML, EXPECTED VALUE OF SAMPLE IS 3.0 NG/ML. NO SAMPLE MATERIAL OR ADDITIONAL DATA ARE AVAILABLE FOR INVESTIGATION, THEREFORE THE INVESTIGATION UNIT WAS UNABLE TO VERIFY THE CUSTOMER COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS E MODULE CK MB REAGENT IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS E170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA