BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYB

    MDR report key: 1488318 · Received October 1, 2009

    Report

    Report Number
    1034569-2009-00333
    Event Type
    Malfunction
    Date Received
    October 1, 2009
    Date of Event
    September 4, 2009
    Report Date
    September 28, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    102116 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH SELECTED FY(A+B+), FY(A+B+W), AND FY(B-) REAGENT RED CELLS USING RETENTION ANTI-FYB, LOTS 613003 AND 613004. ALL FY(A+B+) CELLS EXHIBITED 1+ TO 3+ REACTIVITY AT IAT AND ALL FY(B-) CELLS WERE NONREACTIVE. WEAK REACTIVITY (W+) WAS OBSERVED WITH THE FY(A+B+W) CELL. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH CUSTOMERS' RETURNED DONOR SAMPLE USING RETENTION ANTI-FYB, LOTS 613003 AND 613004. SAMPLE EXHIBITED VERY WEAK (+W) REACTIVITY AT IAT WITH BOTH ANTI-FYB REAGENTS. DAT PERFORMED ON SAMPLE WAS NONREACTIVE. THE SAMPLE IS FY(B+W).

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THEY GOT UNEXPECTED NEGATIVE REACTIONS WITH ANTI-FYB, LOT 613003 WHEN TESTING A DONOR SAMPLE ON TWO OCCASIONS.2 PATIENTS WERE TRANSFUSED WITH THE DONOR UNITS. NO PATIENTS THAT REQUIRED FYB NEGATIVE UNITS WERE TRANSFUSED THIS DONOR'S RED BLOOD CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYB BLOOD GROUPING SERUM KSZ IMMUCOR 513003

    Patients

    Seq Age Sex Outcome Treatment
    1