BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI A (MURINE MONOCLONAL) SERIES 1

    MDR report key: 1004479 · Received December 3, 2007

    Report

    Report Number
    1034569-2007-00316
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    November 5, 2007
    Report Date
    November 30, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102691 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DHR REVIEW FOR ANTI-A (MURINE MONOCLONAL) SERIES 1, 101674 DID NOT REVEAL ANY DEVIATIONS FROM PROCESSES IN THE MANUFACTURE OF THE PRODUCT. THE LOT MET ALL SPECIFICATIONS FOR IN-PROCESS AND FINAL RELEASE CRITERIA . 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. TESTING OF 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 IN 2007. HOWEVER, THIS CUSTOMER HAD NOT LOADED THE REVISED ASSAY AT THE TIME OF THE COMPLAINT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ABO RH DISCREPANCIES ON GALILEO USING THE REFLEX FWD ABORH ASSAY .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI A (MURINE MONOCLONAL) SERIES 1 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 101674

    Patients

    Seq Age Sex Outcome Treatment
    1