BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN

    MDR report key: 2070596 · Received April 12, 2011

    Report

    Report Number
    9610824-2011-00045
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STN# 125098.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH ANTI-HUMAN GLOBULIN, ANTI-IGG SOLIDSCREEN II. THE SAMPLE WAS SUPPOSED TO CONTAIN AN ANTI-JK(B). WE RECEIVED THE PATIENT SAMPLE BUT NOT THE COMPLAINED LOT OF ANTI-HUMAN GLOBULIN, ANTI-IGG SOLIDSCREEN II. THE PATIENT SAMPLE WAS TESTED WITH THE RETENTION SAMPLE ON TANGO IN THE QUALITY CONTROL LABORATORY AND REACTED NEGATIVELY. FURTHERMORE, THE SAMPLE WAS TESTED ON GELCARD AND REACTED ALSO NEGATIVE. A FURTHER TESTING SHOWED A POSITIVE REACTION OF THE SAMPLE ONLY IN THE POLYETHYLENEGLYCOL (PEG) METHOD. 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 LKJ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7016110-05

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO OPTIMO: SERIAL # (B)(4)| ORTHO IGG GEL CARD: LOT 102010001-23| ORTHO 0, 8% SCREENING CELLS: LOT VSS370| EXP. 09/02/2011| EXP. 04/05/2011| BIOTESTCELL 3: (816085100), LOT 8107011| MLB2: (805200100), LOT 7036120, EXP. 08/28/2012| ORTHO RESOLVE ANEL A: LOT VRA153, EXP. 04/05/2011| EXP. 04/05/2011| SOLIDSCREEN II STRIP: (806521100), LOT 7039040| EXP. 09/23/2012