BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-A (MURINE MONOCLONAL) SERIES 1

    MDR report key: 1031635 · Received April 22, 2008

    Report

    Report Number
    1034569-2008-00122
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 16, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102691 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FWD_ABORH TESTING WAS PERFORMED ON AN IN-HOUSE GALILEO WITH IN-HOUSE DONOR SAMPLES OF VARIOUS ABO AND RH TYPES USING RETENTION ANTI-A, LOT 101679, ANTI-B SERIES 3, LOT 203234, ANTI-D SERIES 4, LOT 504697, AND MONOCLONAL CONTROL, LOT 492028. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED WITH NO DISCREPANCIES. TESTING PERFORMED WITH RETENTION ANTI-A, LOT 101673, 101674 WITH IN HOUSE DONOR SAMPLES REVEALED TYPE A RED CELL STICKING IN THE ANTI-A WELLS. TO PREVENT THE STICKING, IN HOUSE STUDIES FOUND THAT PIPETTING THE REAGENTS INTO THE WELLS BEFORE THE SAMPLE RED CELLS GREATLY REDUCED THE STICKING. IN HOUSE COMPARISON TESTING OF THE NEW REAGENT-FIRST PIPETTING ORDER TO THE EXISTING SAMPLE-FIRST PIPETTING ORDER SHOWED NO UNEXPECTED NEGATIVE ANTI-A REACTIONS WITH THE NEW PIPETTING ORDER. SOME UNEXPECTED NEGATIVE REACTIONS WERE OBSERVED DURING TESTING WITH THE CURRENT ASSAY. CUSTOMERS WERE NOTIFIED OF THE MODIFICATION TO THE ASSAY ON 9/20/07.THIS FACILITY DID NOT HAVE THE MODIFIED ABO ASSAY SOFTWARE INSTALLED. 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 AN ABO MISTYPE ON GALILEO PERFORMING FWD_ABO ASSAY. THE DONOR SAMPLE IS HISTORICALLY A POSITIVE AND THE GALILEO INTERPRETED IT AS O POSITIVE.THE PROBLEM WAS OBSERVED WITH ADDITIONAL SAMPLES THAT WERE HISTORICALLY A POSTIIVE BUT REPORTED AS O POSTIIVE IN THE SAME WEEK, ACCORDING TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-A (MURINE MONOCLONAL) SERIES 1 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 101673

    Patients

    Seq Age Sex Outcome Treatment
    1