BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-B (MURINE MONOCLONAL) SERIES 3

    MDR report key: 1024401 · Received April 7, 2008

    Report

    Report Number
    1034569-2008-00094
    Event Type
    Malfunction
    Date Received
    April 7, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 28, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102692 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT IMAGES WERE REVIEWED; THE UNEXPECTED RESULTS WERE CONFIRMED. FWD_ABORH TESTING PERFORMED ON IN-HOUSE GALILEO WITH DONOR SAMPLES OF VARIOUS ABO TYPES AND CUSTOMER'S DONOR SEGMENT 40FY50222 USING RETENTION ANTI-B SERIES 3, LOT 203234. NO ABO DISCREPANCIES WERE OBSERVED. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. CUSTOMER'S SAMPLE WAS INTERPRETED AS GROUP A, D NEGATIVE AS EXPECTED.FWD_ABORH TESTING PERFORMED ON IN-HOUSE GALILEO WITH DONOR SAMPLES OF VARIOUS ABO TYPES AND CUSTOMER'S DONOR SEGMENT 40FY50222 USING RETURNED ANTI-B SERIES 3, LOT 203234. NO ABO DISCREPANCIES WERE OBSERVED. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. CUSTOMER'S SAMPLE WAS INTERPRETED AS GROUP A, D NEGATIVE AS EXPECTED.ACCORDING TO THE GALILEO OPERATOR MANUAL,FORWARD ONLY ABO-RH TESTING HAS A HIGHER RISK OF MISTYPE DUE TO THE ABSENCE OF THE REVERSE TYPE RESULTS. HAZARDOUS MISTYPES MAY OCCUR, SUCH AS AN A SAMPLE BEING INTERPRETED AS A GROUP AB, OR AN RH (D) NEGATIVE SAMPLE BEING INTERPRETED AS RH(D) POSITIVE. FOR THIS REASON, ABO-RH RESULTS SHOULD ALWAYS BE COMPARED TO THE PATIENT OR DONOR'S HISTORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ABO DISCREPANCY ON THE GALILEO. WHEN TESTING WITH THE FWD_ABO ASSAY, A DONOR SAMPLE TYPED AS AB NEGATIVE. MANUAL TESTING RESULTS WERE A NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-B (MURINE MONOCLONAL) SERIES 3 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 203234

    Patients

    Seq Age Sex Outcome Treatment
    1