BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-CMV

    MDR report key: 2181864 · Received July 28, 2011

    Report

    Report Number
    1034569-2011-00101
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 27, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    K910003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNOLOGIST PERFORMING TEST REPORTED THAT SAMPLE WAS COLLECTED IN A GEL SEPARATOR TUBE. PACKAGE INSERT STATES SAMPLES COLLECTED IN GEL SEPARATOR CAN PRODUCE (B)(6) RESULTS. SAMPLE RELATED ISSUE CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED (B)(6) WITH CAPTURE-CMV TESTING OF PATIENT SAMPLE WHEN TESTING IN MANUAL CAPTURE-CMV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-CMV SOLID PHASE SYSTEM FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO CMV KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1