BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANTI-FYB (ANTI-DUFFY) FOR INDIRECT ANTIGLOBULIN TEST

    MDR report key: 461455 · Received May 15, 2003

    Report

    Report Number
    2250051-2003-00111
    Event Type
    Other
    Date Received
    May 15, 2003
    Date of Event
    April 17, 2003
    Report Date
    May 12, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LSE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT NEGATIVE REACTIONS WERE OBSERVED WITH THIS LOT OF ANTI-FYB AND SEVERAL FYB+ CELLS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYB (ANTI-DUFFY) FOR INDIRECT ANTIGLOBULIN TEST BLOOD GROUPING REAGENT LSE ORTHO-CLINICAL DIAGNOSTICS NI FYB53A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO