BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-S

    MDR report key: 939471 · Received April 13, 2007

    Report

    Report Number
    1034569-2007-00068
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Date of Event
    March 13, 2007
    Report Date
    April 13, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    GMQ
    PMA / PMN Number
    BK950017
    Removal / Correction Number
    FA-06-12
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED WITH RETENTION CAPTURE-S INDICATOR CELLS (CSIC), LOTS 229027, 229028, AND 229029, USING CS REACTIVE CONTROL SERUM, AND CS NONREACTIVE CONTROL SERUM. WITH CSIC, LOT 229027, THE REACTIVE CONTROLS EXHIBITED WEAK TO MODERATE REACTIVITY. WITH CSIC, LOT 229028, VERY WEAK TO WEAK REACTIVITY WAS OBSERVED, AND WITH CSIC, LOT 229029, ALL REACTIONS WERE NEGATIVE, WITH SOME FUZZY BUTTONS OBSERVED. TESTING WAS PERFORMED ON AN IN-HOUSE GALILEO USING CSIC, LOTS 229028 AND 229029 USING CS REACTIVE CONTROL SERUM. THREE TEST RUNS WERE PERFORMED USING DIFFERENT COMBINATIONS OF CSIC AND REACTIVE CONTROLS. ALL RUNS WERE INVALID DUE TO FAILURE OF CONTROLS TO MEET CUT-OFF REACTIVITY. CSIC, LOTS 229028 AND 229029 WERE INVESTIGATED AND RAW MATERIAL WAS DETERMINED AS THE ROOT CAUSE OF THE WEAKENED REACTIVITY SEEN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-S INDICATOR CELLS, LOT 229018. CAPTURE S POSITIVE CONTROLS WERE NOT WORKING ON THE DIAS OR THE GALILEO, THE CONTROLS RAN TWICE ON THE DIAS AND THREE TIMES ON THE GALILEO. REPEAT TESTING WAS PERFORMED WITH THE SAME POSITIVE CONTROL (LOT 250149) AND A NEW VIAL OF INDICATOR (LOT 229029) BUT THE POSITIVE CONTROL FAILED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-S GMQ GMQ IMMUCOR, INC. * 229028

    Patients

    Seq Age Sex Outcome Treatment
    1