BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-CMV

    MDR report key: 956365 · Received April 27, 2007

    Report

    Report Number
    1034569-2007-00094
    Event Type
    Malfunction
    Date Received
    April 27, 2007
    Date of Event
    April 4, 2007
    Report Date
    April 27, 2007
    Manufacturer
    IMMUCOR
    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

    CUSTOMER RETURNED SAMPLES FOR TESTING. SAMPLES WERE TESTED WITH RETENTION CAPTURE CMV, LOT C047. IN-HOUSE DONOR SAMPLES OF KNOWN CMV STATUS WERE ALSO INCLUDED IN THE TESTING. THE CUSTOMER'S SAMPLES EXHIBITED POSITIVE REACTIVITY. IN-HOUSE DONOR SAMPLES REACTED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS WITH CAPTURE CMV ON DONOR SAMPLES. THE UNEXPECTED POSITIVE REACTIONS WERE OBSERVED IN DONOR SAMPLES THAT PREVIOUSLY TESTED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-CMV MZE MZE IMMUCOR * C047

    Patients

    Seq Age Sex Outcome Treatment
    1