BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL)

    MDR report key: 2101873 · Received April 19, 2011

    Report

    Report Number
    9610824-2011-00051
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    February 17, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    DEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: THE TESTING OF THE QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED LOT OF ANTI-HUMAN GLOBULIN, ANTI-IGG, -C3D; POLYSPECIFIC. THE REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT. STN # 125242.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED A FALSE NEGATIVE REACTION OF A CAP DAT SURVEY (CAP 2011 DAT-A) WITH 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 DEW BIO-RAD MEDICAL DIAGNOSTICS GMBH 7913070-02

    Patients

    Seq Age Sex Outcome Treatment
    1