BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN (RABBIT, POLYCLONAL)

    MDR report key: 2003154 · Received February 4, 2011

    Report

    Report Number
    9610824-2011-00011
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 3, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    DEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN ACCORDANCE TO THE RESULTS OBTAINED AT THE CUSTOMER SITE, TESTING AT BMD CONFIRMED A CARRY-OVER EVENT FROM ONE WELL INTO THE FOLLOWING ONE OCCURRING DURING SEQUENTIAL PIPETTING OF DIFFERENT BLOOD PLASMA CAUSED BY THE TREMENDOUS TITRE OF ANTIBODY PRESENT IN THE ORIGINAL SAMPLE. EACH PIPETTING STEP OF INDIVIDUAL SAMPLES IS FOLLOWED BY A RINSING STEP OF THE CORRESPONDING NEEDLE RESULTING IN A DILUTION BIOLOGICAL RESIDUES BY APPROX. 1:1000. IN GENERAL THIS DILUTION FACTOR IS SUFFICIENT TO PREVENT A DETECTABLE TRANSFER OF MATERIAL INTO THE FOLLOWING SPECIMEN.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THEY HAD A PT WITH A STRONG ANTI-D WHICH RESULTED IN THE FOLLOWING SAMPLE TO REACT IN A FALSE POSITIVE ANTIBODY SCREEN. THE CUSTOMER SUSPECTED THE FALSE POSITIVE REACTION WAS A RESULT OF THE STRONG ANTI-D SO SHE REPEATED THE FALSE POSITIVE ANTIBODY SCREEN AND REC'D A NEGATIVE ANTIBODY SCREEN RESULT. THE CUSTOMER SAVED THE SAMPLE WITH THE STRONG ANTIBODY AS SHE EXPECTED A FORMAL WORKUP WOULD BE PERFORMED. IN GENERAL CARRY-OVER EVENTS CANNOT BE EXCLUDED IF APPLYING INSTRUMENTATION WITH A DESIGN LAYOUT, THAT IS AMONGST OTHERS, ALSO TRUE FOR TANGO OPTIMO. THIS MATTER IS ALSO DISPLAYED IN ITS SPECIFICATIONS. DESPITE COATED NEEDLES AS WELL AS RINSING STEPS, SUCH A PHENOMENON MAY OCCUR IN VERY RARE CASES, IS USUALLY BASED ON A SAMPLE-SPECIFIC REACTION AND CAN BE CAUSED BY A HIGH PROTEIN LEVEL IN PLASMA (INDUCED BY SEVERE SICKNESS OR APPLICATION OF DRUGS) OR ANTIBODIES WITH A HIGH TITRE. SINCE ANY SPECIMEN BEING CONSPICUOUS DUE TO A POSITIVE ABS RESULT SHOULD UNDERGO RETESTING AND BECAUSE ANY ABS- POSITIVE SAMPLE FROM A BLOOD DONOR SHOULD BE EXCLUDED FROM TRANSFUSION, NO SERIOUS THREAT NEITHER FOR PT NOR USER OF DEVICE MAY ARISE DUE TO A CARRY-OVER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN (RABBIT, POLYCLONAL) ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN DEW BIO-RAD MEDICAL DIAGNOSTICS GMBH 7016110-03

    Patients

    Seq Age Sex Outcome Treatment
    1 EXP 7/8/2012| MLB2 (805200100): LOT 7013110, EXP 3/19/2012| BIOTESTCELL 3 (816085100): LOT 7047011,| EXP 1/11/2011| SOLIDSCREEN II PLATES (806521100): LOT 7028010,