BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKB BIOCLONE

    MDR report key: 661001 · Received December 29, 2005

    Report

    Report Number
    2250051-2005-50579
    Event Type
    Malfunction
    Date Received
    December 29, 2005
    Date of Event
    December 1, 2005
    Report Date
    December 29, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A FALSE POSITIVE RESULT WAS OBTAINED WHEN A PT SAMPLE WAS TESTED WITH ANTI-JKB LOT JBB392A. NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-JKB BIOCLONE BLOOD GROUPING REAGENT KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. NA JBB392A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other