BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-B (MURINE MONOCLONAL) SERIES 3

    MDR report key: 1306343 · Received February 9, 2009

    Report

    Report Number
    1034569-2009-00038
    Event Type
    Malfunction
    Date Received
    February 9, 2009
    Date of Event
    January 16, 2009
    Report Date
    February 6, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    102692 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION TESTING OF ANTI-B SERIES 3, LOT 203239 WAS PERFORMED AS EXPECTED. CUSTOMER WAS GIVEN GUIDANCE FROM THE GALILEO OPERATOR MANUAL WHICH STATES THAT 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 GROUP AB, OR AN RH (D) NEGATIVE SAMPLE BEING INTERPRETED AS RH (D). FOR THIS REASON, ABO RESULTS SHOULD ALWAYS BE COMPARED TO THE PATIENT OR DONOR'S HISTORY. THE CUSTOMER DOES NOT HAVE SAMPLE TO RETURN FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ABO DISCREPANCY ON THE GALILEO USING THE FWD-ABO ASSAY; UNEXPECTED POSITIVE REACTIONS WERE OBSERVED FOR ANTI-B SERIES 3. THE GALILEO INTERPRETED A PATIENT SAMPLE AS AB POSITIVE. THE SAMPLE WAS RETESTED AND WAS A POSITIVE. NO ADVERSE EFFECTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-B (MURINE MONOCLONAL) SERIES 3 BLOOD GROUPING REAGENT KSZ IMMUCOR 203239

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR