BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYA

    MDR report key: 1474606 · Received September 17, 2009

    Report

    Report Number
    1034569-2009-00307
    Event Type
    Malfunction
    Date Received
    September 17, 2009
    Date of Event
    August 18, 2009
    Report Date
    September 16, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    102115 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANTI-FYA, LOT 607001-1, EXPIRED BEFORE COMPLAINT WAS RECEIVED. RETENTION TESTING HAD BEEN PERFORMED WITH THIS LOT WHILE PRODUCT WAS INDATE, AND PRODUCT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A DONOR UNIT WITH ANTI-FYA, LOT 607001-1. THE UNIT WAS SENT TO A FACILITY TYPED AS FYA NEGATIVE, BUT WAS INCOMPATIBLE WHEN TESTED WITH PATIENT'S SAMPLE CONTAINING ANTI-FYA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYA BLOOD GROUP REAGENT KSZ IMMUCOR 607001-1

    Patients

    Seq Age Sex Outcome Treatment
    1