BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2149050 · Received June 17, 2011

    Report

    Report Number
    9610824-2011-00082
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED FALSE (B)(6) REACTIONS OF PT SAMPLES WITH CELL 2 OF BIOTESTCELL 3 IN THE GEL CARD. WE RECEIVED THREE AFFECTED SAMPLES BUT NOT THE COMPLAINED LOT OF BIOTESTCELL 3. THE SAMPLES PLUS THE RETENTION SAMPLE OF BIOTESTCELL 3 WERE TESTED WITH A GEL CARD IN OUR QC LAB. THE THREE SAMPLES SHOWED (B)(6) REACTIONS WITH CELL 2 OF BIOTESTCELL 3. FURTHERMORE THE SAMPLES WERE TESTED IN THE 3-PHASE-TUBE TEST AND REACTED (B)(6). THE THREE SAMPLES SHOWED ONLY (B)(6) REACTIONS IN A TUBE METHOD WITH PROLONGED INCUBATION TIME AT 4 DEGREES CELSIUS. BUT THIS METHOD IS NOT CONFORM TO THE DESCRIBED METHODS OF INSTRUCTION FOR USE. THE CORRECT FUNCTION OF THE AFFECTED LOT BIOTESTCELL 3 WAS CONFIRMED BY TESTING DIFFERENT (B)(6) SAMPLES. ALL (B)(6) REACTIONS WERE CORRECT. THE CUSTOMER SAMPLES REACTED (B)(6) 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 AND NOT THE GEL SYSTEM.

    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 ORTHO PANEL C: LOT RC380