BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN

    MDR report key: 2070595 · Received April 12, 2011

    Report

    Report Number
    9610824-2011-00043
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 8, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    DEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STN #: 125098.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED FALSE NEGATIVE REACTIONS OF A PROFICIENCY SAMPLE (AUT-02) CONTAINING ANTI-E. WE RECEIVED THE PROFICIENCY SAMPLE (AUT-02) BUT NOT THE COMPLAINED LOT OF ANTI-HUMAN GLOBULIN, ANTI-IGG SOLIDSCREEN II. THE PROFICIENCY SAMPLE WAS TESTED WITH THE RETENTION SAMPLE ON TANGO IN THE QUALITY CONTROL LABORATORY AND REACTED NEGATIVELY. FURTHERMORE, A TWOFOLD SERIAL DILUTION WAS TESTED ON SOLIDSCREEN II AND REACTED CORRECTLY POSITIVE. REFERRED TO INFORMATIONS OF CUSTOMER THE PROFICIENCY SAMPLE AUT-02 CONTAINS A MONOCLONAL ANTI-E AND NOT A NATURAL OCCURRING ANTIBODY. THE INTENDED USE OF SOLIDSCREEN IS, AMONGST OTHERS, THE DETECTION OF IRREGULAR RED CELL ANTIBODIES IN HUMAN BLOOD. THE CORRECT FUNCTION OF THE AFFECTED LOT ANTI-HUMAN GLOBULIN, ANTI-IGG SOLIDSCREEN II WAS CONFIRMED BY TESTING DIFFERENT WEAK ANTIBODIES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN DEW BIO-RAD MEDICAL DIAGNOSTICS GMBH 7016110-05

    Patients

    Seq Age Sex Outcome Treatment
    1 BIOTESTCELL 3: (816085100), LOT 7051011| MLB2: (805200100), LOT 7025121, EXP. 06/10/2012| EXP. 02/08/2011| TANGO OPTIMO: SERIAL NUMBER (B)(4)