BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYA

    MDR report key: 4102566 · Received September 19, 2014

    Report

    Report Number
    1034569-2014-00170
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 19, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 125493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT REPLACEMENT VIALS OF THE SAME LOT OF IMMUCOR ANTI-FYA. THE CUSTOMER PERFORMED QC ON THE NEW VIALS. POSITIVE (2+) REACTIVITY WAS OBTAINED WITH THE HETEROZYGOUS FYA-POSITIVE CELL. NO REPEAT TESTING WAS PERFORMED WITH THE DONOR SAMPLES. WE WERE UNABLE TO RULE OUT THAT ORIGINAL VIALS MAY HAVE BECOME COMPROMISED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY WITH DONOR SAMPLES WHEN USING BLOOD GROUPING REAGENT ANTI-FYA, LOT 618004L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581388 ANTI-FYA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 618004L

    Patients

    Seq Age Sex Outcome Treatment
    1