BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL-I11

    MDR report key: 2070548 · Received April 4, 2011

    Report

    Report Number
    9610824-2011-00037
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A KNOWN COMBINED ANTI-E AND ANTI-C WITH BIOTESTCELL-I11. CUSTOMER SENT US THE PATIENT SAMPLE BUT NOT THE COMPLAINED LOT OF BIOTESTCELL-I11. THE SAMPLE WAS TESTED WITH THE RETENTION SAMPLE OF BIOTESTCELL-I11 IN THE INDIRECT ANTI-HUMAN GLOBULIN TECHNIQUE. THE SAMPLE REACTED POSITIVELY. FURTHERMORE THE SAMPLE WAS TESTED IN THE ENZYME METHOD AND REACTED STRONGLY POSITIVE. THE SAMPLE WAS ALSO TESTED IN THE LISS/COOMBS GELCARD OF DIAMED AND REACTED ALSO POSITIVE. THE PERFORMED TESTS CONFIRM THE WEAKNESS OF THE ANTI-C AND THE PREFERENCE OF THE ANTI-E FOR REACTING IN ENZYME TECHNIQUE. ADDITIONALLY THE AFFECTED LOT OF BIOTESTCELL-I11 WAS TESTED WITH A KNOWN ANTI-E AND ANTI-C. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL-I11 BIOTESTCELL-I11 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8105011

    Patients

    Seq Age Sex Outcome Treatment
    1 COOMBSCELL E: LOT 8105011, EXP. 03/22/2011| MLB 2: LOT 7025121, EXP. 06/10/2012