BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2149044 · Received June 15, 2011

    Report

    Report Number
    9610824-2011-00080
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STN # 125207-08.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED FALSE POSITIVE REACTIONS OF THREE PATIENT SAMPLES WITH CELL 2 OF BIOTESTCELL 3 IN THE GEL CARD. WE RECEIVED ONE OF THE THREE AFFECTED SAMPLES AND THE COMPLAINED LOT OF BIOTESTCELL 3. THE SAMPLE WAS TESTED WITH COMPLAINT AND RETENTION SAMPLE OF BIOTESTCELL 3 IN GEL CARD IN OUR QUALITY CONTROL LABORATORY. THE SAMPLE REACTED POSITIVE WITH CELL 2 OF BOTH BIOTESTCELL 3. FURTHERMORE, THE SAMPLE WAS TESTED IN THE GEL METHOD AT 4 DEGREES CELSIUS. ALL THREE CELLS OF BIOTESTCELL 3 AND THE AUTOCONTROL REACTED POSITIVE. ADDITIONALLY, THE SAMPLE WAS TESTED IN THE TUBE TECHNIQUE (LISS 10 MIN AT 37 DEGREES CELSIUS AND INDIRECT ANTI-HUMAN GLOBULIN TEST). IT REACTED NEGATIVE IN THE TUBE METHODS. THE CORRECT FUNCTION OF THE AFFECTED LOT BIOTESTCELL 3 WAS CONFIRMED BY TESTING DIFFERENT POSITIVE AND NEGATIVE SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ONLY THE CUSTOMER SAMPLE REACTED POSITIVE WITH CELL 2 OF BIOTESTCELL 3 IN THE GEL CARD. THE INTENDED USE OF THE PRODUCT IS THE DETECTION OF UNEXPECTED ANTIBODIES IN THE TUBE TEST AND SOLID PHASE TEST SOLIDSCREEN II WITH TANGO OPTIMO.

    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 8115011

    Patients

    Seq Age Sex Outcome Treatment
    1