BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID TEST WELLS

    MDR report key: 968146 · Received May 11, 2007

    Report

    Report Number
    1034569-2007-00107
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    April 10, 2007
    Report Date
    May 10, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DOES NOT HAVE SAMPLE TO RETURN FOR INVESTIGATION TESTING. 4_CELL AND AB_ID TESTING WERE PERFORMED ON AN IN-HOUSE GALILEO WITH RETENTION CAPTURE-R READY-SCREEN (4,) CAPTURE-R READY-ID, LOT ID082 AND CAPTURE-R INDICATOR RED CELLS USING IN-HOUSE DONOR SAMPLES. NO EXPECTED POSITIVE OR EQUIVOCAL RESULTS WERE OBSERVED. ALL IN-HOUSE DONOR SAMPLES WERE NONREACTIVE AS EXPECTED. 2_CELL SCREEN TESTING WAS ALSO PERFORMED ON AN IN-HOUSE GALILEO WITH RETENTION CAPTURE-R READY-SCREEN (I AND II), LOT X185 AND CAPTURE-R INDICATOR RED CELLS, LOT 221996 USING IN-HOUSE DONOR SAMPLES. ALL IN-HOUSE DONOR SAMPLES WERE NONREACTIVE AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 2 PATIENT SAMPLES TESTED POSITIVE WITH 2_CELL SCREEN, BUT NEGATIVE WITH ABID ASSAY ON GALILEO USING CRRID TEST WELLS. A NEGATIVE DAT WAS PRESENT FOR EACH SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-ID TEST WELLS REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. * ID082

    Patients

    Seq Age Sex Outcome Treatment
    1 * CAPTURE-R READY-SCREEN (I AND II)| LOT 221996| CAPTURE-R INDICATOR RED CELLS| LOT X185