BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYA

    MDR report key: 1024400 · Received April 7, 2008

    Report

    Report Number
    1034569-2008-00097
    Event Type
    Malfunction
    Date Received
    April 7, 2008
    Date of Event
    March 19, 2008
    Report Date
    April 3, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102115 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH IN HOUSE SAMPLES USING SELECTED FY(A+B+) AND FY(A-) CELLS FROM PANOCELL-10, LOT 05500, AND PANOCELL-20, LOT 04478. ALL FY(A+) CELLS EXHIBITED 2+ TO 2+S REACTIVITY AND ALL FY(A-) CELLS WERE NONREACTIVE. EMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH THE RETURNED DONOR'S SEGMENT USING RETENTION ANTI-FYA, LOT FYA63H-1. THE SAMPLE EXHIBITED 2+ REACTIVITY AT IAT.

    Description of Event or Problem · 1

    CUSTOMER OBTAINED NEGATIVE REACTIVITY WHEN TESTING A DONOR UNIT WITH ANTI-FYA. DURING CROSSMATCH OF THAT UNIT (WITH A PATIENT SAMPLING CONTAINING ANTI-FYA), THE UNIT WAS FOUND AS INCOMPATIBLE. THIS INCIDENT DID NOT RESULT IN THE RELEASE OF ANY UNITS THAT WERE MISTYPED BY THIS REAGENT; INCOMPATIBILITY WAS DISCOVERED DURING CROSSMATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. FYA63H-1

    Patients

    Seq Age Sex Outcome Treatment
    1