BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYB

    MDR report key: 3262495 · Received August 2, 2013

    Report

    Report Number
    1034569-2013-00142
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Date of Event
    July 18, 2013
    Report Date
    August 2, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUBMITTED 4 SEGMENTS FOR INVESTIGATION. IN-HOUSE TESTING WAS PERFORMED USING RETENTION ANTI-FYB, LOTS 613014 (EXPIRED), 613017 AND 613021. POSITIVE RESULTS WERE OBTAINED WITH ALL THREE LOTS. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT POSITIVE RESULTS WERE RECENTLY OBTAINED FOR A PATIENT SAMPLE THAT PREVIOUSLY RESULTED AS NEGATIVE WHEN TESTING WITH IMMUCOR ANTI-FYB, LOT 613014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363251 ANTI-FYB BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 613014

    Patients

    Seq Age Sex Outcome Treatment
    1