BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2070570 · Received April 4, 2011

    Report

    Report Number
    9610824-2011-00038
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    January 28, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    PMA / PMN Number
    125207-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF FALSE NEGATIVE REACTIONS OF A PROFICIENCY SAMPLE (AUT-02) CONTAINING ANTI-E. WE RECEIVED THE PROFICIENCY SAMPLE (AUT-02) BUT NOT THE COMPLAINT LOT OF BIOTESTCELL 3. 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 INFORMATION 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 BIOTESTCELL 3 WAS CONFIRMED BY TESTING DIFFERENT WEAK ANTIBODIES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. TESTING AT THE QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINT LOT OF BIOTESTCELL 3. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL 3 BIOTESTCELL 3 LKJ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7051021

    Patients

    Seq Age Sex Outcome Treatment
    1 MLB 2: LOT # 7025121, EXP 06/10/2012| AHG ANTI-IGG SOLIDSCREEN II: LOT # 7949130-03| EXP 05/25/2011| SOLIDSCREEN II STRIP: LOT #7015020, EXP 04/08/2012