BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-B (MURINE MONOCLONAL) SERIES 3

    MDR report key: 1601500 · Received February 17, 2010

    Report

    Report Number
    1034569-2010-00046
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    January 21, 2010
    Report Date
    February 15, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS FILES: THERE IS STRONG AGGLUTINANT PRESENT IN WELL A2 AT 4+. WELL B2 HAS A POOLING OF CELLS CENTERED IN THE WELL BUT NOT FORMING A TIGHT CELL BUTTON, READING AT 3+. THE MONOCLONAL CONTROL IS NEGATIVE. WELL G2 (B CELLS) HAS A SHADOWING OF CELLS TOWARDS THE CENTER OF THE WELL BUT NO CELL BUTTON PRESENT. THE MANUAL TEST GAVE A A POS WITH ANTI-A AT 4+, ANTI-B AT 0, ANTI-D 4+ , A1 AT 0 AND B CELLS AT 2+. VISIBLY IT DOESN'T APPEAR TO HAVE ASPIRATED A CLOT NOR TO HAVE FIBRIN PRESENT. ABORH ASSAY PERFORMED WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES USING RETENTION ANTI-A, LOT 101700, ANTI-B SERIES 3, LOT 203260, A1 REFERENCELLS AND B REFERENCELLS ON IN-HOUSE GALILEO. NO ABO DISCREPANCIES WERE OBSERVED. ABORH ASSAY PERFORMED WITH CUSTOMER'S DONOR SAMPLE USING RETENTION ANTI-A, LOT 101700, ANTI-B SERIES 3, LOT 203260, A1 REFERENCELLS AND B REFERENCELLSON IN-HOUSE GALILEO. PLASMA EXHIBITED 3+ HEMOLYSIS AND WAS INTERPRETED AS NTD POSITIVE. FWD_ABORH ASSAY WAS PERFORMED WITH CUSTOMER'S DONOR SAMPLE AND WAS INTERPRETED AS A POSITIVE, AS EXPECTED. RETENTION PRODUCTS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ABO DISCREPANCY ON THE GALILEO. A DONOR SAMPLE WAS TESTED AND RESULTED AS AB POSITIVE. THE FORWARD TYPING WAS AB AND THE REVERSE TYPING WAS A. IT REFLEXED AND BOTH THE FORWARD AND THE REVERSE WERE AB POSITIVE. THE SEGMENT CONFIRMATORY TEST RESULTED A POSITIVE. THE DONOR WAS A KNOWN A POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-B (MURINE MONOCLONAL) SERIES 3 BLOOD GROUPING REAGENT KSZ IMMUCOR 203260

    Patients

    Seq Age Sex Outcome Treatment
    1