BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYB

    MDR report key: 943022 · Received April 18, 2007

    Report

    Report Number
    1034569-2007-00081
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Date of Event
    March 21, 2007
    Report Date
    April 18, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH RETURNED AND RETENTION ANTI-FYB, LOT FYB67H-3 USING RETENTION PANOSCREEN I AND II, LOT 06773. BOTH RETURNED AND RETENTION ANTI-FYB EXHIBITED POSITIVE REACTIVITY (2 + TO 2+S) WITH CELL II [FY (A+B+)] AND CELL II [FY (A+B+)]. PRODUCTS PERFORMED AS EXPECTED. HEMAGGLUTINATION TUBE TESTING PERFORMED WITH RETURNED AND RETENTION ANTI-FYB, LOT FYB67H-3 USING FY(A+B+), FY (A+B+W), AND FY(B-) CELLS FROM RETENTION PANOCELL-20, LOT 09826. PRODUCTS PERFORMED AS EXPECTED. FY (A+B+W) CELL EXHIBITED +W REACTIVITY, FY (A+B+) CELLS EXHIBITED 2+ TO 2+S REACTIVITY, AND FY(B-) CELLS WERE NEGATIVE WITH RETURNED AND RETENTION ANTI-FYB REAGENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH ANTI-FYB WHEN TESTING HETEROZYGOUS FYB CELLS, CELL #I AND CELL #II OF PANOSCREEN II, LOT 06773. REPEAT TESTING PEFORMED WITH HOMOZYGOUS FYB CELLS RESULTED IN POSITIVE REACTIONS (3+).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYB BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. * FYB67H-3

    Patients

    Seq Age Sex Outcome Treatment
    1 *