BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-S

    MDR report key: 761444 · Received August 3, 2006

    Report

    Report Number
    1034569-2006-00075
    Event Type
    Malfunction
    Date Received
    August 3, 2006
    Date of Event
    July 14, 2006
    Report Date
    August 2, 2006
    Manufacturer
    IMMUCOR, INC.
    Product Code
    GMQ
    PMA / PMN Number
    BK950017
    Removal / Correction Number
    FA-06-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PREVIOUS LOT OF POSITIVE CONTROL, LOT #252006, AND NEGATIVE CONTROL, LOT #251005, USED FOR DAILY QUALITY CONTROL PERFORMED AS EXPECTED, USING THE SAME LOT OF INDICATOR CELLS. THE OLD LOTS OF CONTROLS TESTED WITH A NEW LOT OF INDICATOR CELLS, LOT #229019, PERFORMED AS EXPECTED. RETENTION CAPTURE -S INDICATOR CELLS, LOT 229018 WERE TESTED ON AN IN-HOUSE SEMI-AUTOMATED INSTRUMENT WITH RETENTION CAPTURE-S PLATES, LOT S098; CAPTURE-S REACTIVE CONTROL SERUM, LOT 252007; CAPTURE-S NONREACTIVE CONTROL SERUM, LOT 251006 AND IN-HOUSE DONOR SAMPLES. IN-HOUSE DONOR SAMPLES WERE NONREACTIVE IN ALL TESTING PERFORMED, AS EXPECTED. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEY ARE GETTING UNEXPECTED NEGATIVE REACTIONS WITH POSITIVE CONTROL CELLS, LOT # 252008, EXP. 2/11/07 OF CAPTURE S WHEN PERFORMING THEIR LOT TO LOT QC CAPTURE S INDICATOR CELLS, LOT #229018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-S GMQ GMQ IMMUCOR, INC. * 229018

    Patients

    Seq Age Sex Outcome Treatment
    1