BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR CELLS

    MDR report key: 3254127 · Received July 30, 2013

    Report

    Report Number
    1034569-2013-00134
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    June 15, 2013
    Report Date
    July 30, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGE RESULT FILES WERE REVIEWED. REACTION STRENGTH OF THE PRE-TRANSFUSION SAMPLE WAS VERY LOW AND AT THE LIMIT OF DETECTION FOR THE GALILEO. THE POST-TRANSFUSION SAMPLE WAS VERY STRONG FOLLOWING EXPOSURE. NO RETENTION TESTING WAS PERFORMED WITH LOT 221001, AS THE LOT HAD EXPIRED PRIOR TO RECEIPT OF THE COMPLAINT. THE DEVICE HISTORY RECORD FOR LOT 221001 WAS REVIEWED. THE EXPECTED REACTIVITY WAS OBSERVED IN ALL TESTING. THE PRODUCT PERFORMED ACCORDING TO SPECIFICATIONS PRIOR TO DISTRIBUTION OF PRODUCT. THE UNEXPECTED REACTIVITY APPEARS TO BE SAMPLE-RELATED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIVITY WAS OBTAINED ON THE ANTIBODY SCREENING ASSAY ON THE GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354638 CAPTURE-R READY INDICATOR CELLS ANTI-IGG COATED RED CELLS KSZ IMMUCOR, INC. 221001

    Patients

    Seq Age Sex Outcome Treatment
    1