BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANTI-FYB

    MDR report key: 952002 · Received August 8, 2006

    Report

    Report Number
    2250051-2006-50337
    Event Type
    Other
    Date Received
    August 8, 2006
    Date of Event
    July 11, 2006
    Report Date
    August 8, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    OCD REPORTED THAT ONE OF THEIR CUSTOMERS (OSAKA RED CROSS) OBTAINED WEAK FALSE POSITIVE RESULTS (0.5+) ON MULTIPLE DONOR UNITS TESTED WITH BLOOD GROUPING REAGENT ANTI-FYB, LOT FYB63B. THE FALSE POSITIVE REACTIVITY APPEARED TO BE ASSOCIATED WITH GROUP B DONOR UNITS. NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYB BLOOD GROUPING REPORT KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. NA FYB63B

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other