BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R INDICATOR RED CELLS

    MDR report key: 1001589 · Received February 25, 2008

    Report

    Report Number
    1034569-2008-00033
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 11, 2008
    Report Date
    January 30, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT EXPIRED PRIOR TO RECEIVING THE COMPLAINT. RETENTION TESTING FOR CAPTURE-R INDICATOR RED CELLS, LOT 221107 WAS PERFORMED. NO UNEXPECTED REACTIVITY WAS OBSERVED. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION USING CAPTURE-R INDICATOR RED CELLS ON GALILEO. A PATIENT SAMPLE TESTED POSITIVE IN TUBE AND NEGATIVE ON THE ABID ASSAY ON THE GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSZ IMMUCOR, INC. 221107

    Patients

    Seq Age Sex Outcome Treatment
    1