BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOTESTCELL-P3

    MDR report key: 2070576 · Received March 30, 2011

    Report

    Report Number
    9610824-2011-00036
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    125207-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A KNOWN ANTI-E WITH BIOTESTCELL-P3. CUSTOMER SENT US A PATIENT SAMPLE BUT NOT THE COMPLAINT LOT OF BIOTESTCELL-P3. THIS SAMPLE WAS TESTED WITH THE RETENTION SAMPLE OF BIOTESTCELL-P3 ON TANGO. THE SAMPLE REACTED NEGATIVELY. FURTHERMORE, THE SAMPLE WAS TESTED WITH ENZYME TREATED RED CELLS ON TANGO AND REACTED STRONGLY POSITIVE. THE SAMPLE WAS ALSO TESTED WITH THE LISS/COOMBS GELCARD OF DIAMED AND REACTED NEGATIVELY. THE PERFORMED TESTS CONFIRM THE WEAKNESS OF THIS ANTIBODY AND THE PREFERENCE FOR REACTING IN ENZYME TECHNIQUE. THE AFFECTED LOT OF BIOTESTCELL-P3 WAS TESTED WITH DIFFERENT CONTROLS ON TANGO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTESTCELL-P3 BIOTESTCELL-P3 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 2105011

    Patients

    Seq Age Sex Outcome Treatment
    1 SER. NO. (B)(4)| TANGO OPTIMO: SER. NO. (B)(4)