BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL)

    MDR report key: 1983144 · Received January 17, 2011

    Report

    Report Number
    9610824-2011-00007
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    October 10, 2010
    Report Date
    January 19, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    GMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CAP PROFICIENCY TEST FOR THE DAT B S ON SAMPLE #6 FAILED TO REACT POSITIVELY WITH ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D, POLYSPECIFIC ART NO. 804115100, LOT 7913070-02. THE CUSTOMER HAS SENT US NEITHER THE SURVEY SAMPLE NOR THE COMPLAINED REAGENT. THEREFORE, THE RETENTION SAMPLE WAS TESTED WITH THE SURVEY SAMPLE DAT-06 OF THE QUALITY CONTROL LABORATORY WHICH HAS THE SAME SPECIFICITY AS THE CONTROL USED BY CUSTOMER. THE SURVEY SAMPLE OF QC REACTED CORRECTLY POSITIVE WITH THE AFFECTED LOT OF ANTI-HUMAN GLOBULIN ANTI-IGG, C3D, POLYSPECIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL) ANTI-HUMAN GLOBULIN, ANTI-IGG, -C3D, POLY. GMS BIO-RAD MEDICAL DIAGNOSTICS GMBH 7913070-02

    Patients

    Seq Age Sex Outcome Treatment
    1