BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2261743 · Received August 30, 2011

    Report

    Report Number
    9610824-2011-00117
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 30, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT. TANGO OPTIMO SPECIFIC DATA WERE REQUESTED FOR REVIEW BUT UP TO DATE DESPITE SEVERAL INQUIRIES NOT RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT TWO PT SAMPLES YIELDED FALSE NEGATIVE REACTIONS WITH CELL 1 OF BIOTESTCELL 3. BOTH PTS ARE SUPPOSED TO HAVE AN ANTI-D. WE RECEIVED THE TWO AFFECTED SAMPLES AND THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 3. SAMPLES WERE TESTED WITH THE COMPLAINT SAMPLE AND THE RETENTION SAMPLE OF BIOTESTCELL 3 IN OUR QUALITY CONTROL LABORATORY USING DIFFERENT METHODS. TESTING OF THE ALLEGEDLY DEFECTIVE AND THE RETENTION SAMPLE OF BIOTESTCELL 3 YIELDED COMPARABLE RESULTS. THE PT SAMPLES REACTED WEAKLY POSITIVE WITH CELL 2 OF BIOTESTCELL 3 AND NEGATIVELY WITH CELL 1 OF BIOTESTCELL 3. THE SAMPLES WERE ALSO TESTED USING THE GEL METHOD WITH THE REAGENT RED BLOOD CELLS OF A COMPETITOR. CELL 2 OF THIS SCREENING CELLS REACTED POSITIVELY WHILE CELL 1 RESULTED ONLY IN A +/- REACTION. ALL TESTINGS CONFIRM THE WEAKNESS OF THE TWO ANTIBODIES. MOREOVER THE ANTIGENITY OF THE AFFECTED D ANTIGEN OF DIFFERENT REAGENT RED BLOOD CELLS MAY VARY LIGHTLY. TESTING OF OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 3.

    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 8127011

    Patients

    Seq Age Sex Outcome Treatment
    1 SOLIDSCREEN II STRIP: LOT 8110070, EXP. 02/02/2013| AHG IGG SOLIDSCREEN II: LOT 8102140-04,| BIOTESTCELL 3: LOT 8123011, EXP. 07/26/2011| EXP. 07/06/2012| TANGO OPTIMO: #(B)(4)| MLB2: LOT 8046070, EXP. 11/07/2012