BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-MV

    MDR report key: 942634 · Received April 18, 2007

    Report

    Report Number
    1034569-2007-00076
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Date of Event
    March 21, 2007
    Report Date
    April 18, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    MZE
    PMA / PMN Number
    k91003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED AND RETENTION CAPTURE-CMV, LOT C046 WERE TESTED WITH IN-HOUSE DONORS OF KNOWN CMV STATUS. IN-HOUSE DONOR SAMPLES CMV STATUS WAS CONFIRMED. RETURNED AND RETENTION PRODUCTS PERFORMED AS EXPECTED. CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, UNEXPECTED POSITIVE REACTIONS WITH CAPTURE-CMV WHEN TESTING 2 DONOR SAMPLES THAT PREVIOUSLY TESTED NEGATIVE. REPEAT TESTING ALSO RESULTED AS NEGATIVE. THE SAMPLES TESTED POSITIVE FOR CMV ANTIBODIES BY AN ALTERNATIVE EIA METHOD. NO ADVERSE REACTIONS OCCURRED, HOWEVER, ONE UNIT OF FFP COLLECTED FROM ONE OF THE DONORS WAS RELEASED, BUT NOT TRANSFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-MV MZE MZE IMMUCOR, INC. * C046

    Patients

    Seq Age Sex Outcome Treatment
    1 *