BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2219034 · Received July 21, 2011

    Report

    Report Number
    9610824-2011-00092
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    PMA / PMN Number
    125207-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT PT SAMPLES YIELDED A FALSE (B)(6) REACTION WITH BIOTESTCELL 3 IN THE TUBE TECHNIQUE. WE RECEIVED THE AFFECTED SAMPLE AND THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 3. THE SAMPLE WAS RETESTED WITH COMPLAINT SAMPLE AND RETENTION SAMPLE OF BIOTESTCELL 3 IN TUBE TECHNIQUE IN OUR QUALITY CONTROL LAB. THE PT SAMPLE DISPLAYED A (B)(6) REACTION IN THE INDIRECT ANTI-HUMAN GLOBULIN TEST (IAT). THE SAMPLE WAS ALSO TESTED IN THE GEL METHOD AND REACTED (B)(6). FURTHERMORE THE SAMPLE WAS TESTED WITH THE COMPLAINT SAMPLE OF BIOTESTCELL 3 IN THE ENZYME METHOD AND REACTED (B)(6) WITH THE AFFECTED (B)(6) SCREENING CELL. THE CORRECT FUNCTION OF THE AFFECTED LOT BIOTESTCELL 3 WAS CONFIRMED BY TESTING TWO DIFFERENT ANTI-E FROM AN INTERLABORATORY COMPARISON TESTING. BOTH ANTIBODIES REACTED CORRECTLY (B)(6).

    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 8119011

    Patients

    Seq Age Sex Outcome Treatment
    1 AHG IGG ((B)(4)),LOT 7039091-04,EXP. 09/15/2013| MLB2 ((B)(4)), LOT 7951111, EXP. 12/05/2011| COOMBSCELL E((B)(4)),LOT 8117011,EXP 06/14/2011