BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYA

    MDR report key: 1334542 · Received March 6, 2009

    Report

    Report Number
    1034569-2009-00074
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    February 10, 2009
    Report Date
    March 4, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    102115 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH FY(A+B+) AND FY(A-) CELLS FROM RETENTION PANOCELL-20, LOT 52189, USING ANTI-FYA, LOT FYA64H-1. ALL FY(A-) CELLS WERE NONREACTIVE. ALL FY(A+B+) CELLS EXIBITED 2+ TO 3+S REACTIVITY IN ALL TESTING. RETENTION PRODUCTS PERFORMED AS EXPECTED. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH ANTI-FYA, LOT FYA 64H-1. A UNIT INITIALLY THOUGHT TO BE FY(A-) WAS TRANSFUSED TO A PATIENT WITH AN ANTI-FYA. THE PATIENT WAS DISCHARGED, ADDITIONAL INFORMATION WAS NOT AVAILABLE. PHYSICIAN TO BE NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYA BLOOD GROUPING REAGENT KSZ IMMUCOR FYA64H-1

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR