BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (I AND II)

    MDR report key: 3156985 · Received June 8, 2013

    Report

    Report Number
    1034569-2013-00101
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 7, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED REPEAT TESTING ON THE GALILEO USING A DIFFERENT LOT OF INDICATOR CELLS AND PLATES. NEGATIVE RESULTS WERE AGAIN OBTAINED. MANUAL TUBE TESTING WAS PERFORMED WITH 30-MINUTE ROOM TEMPERATURE INCUBATION AND THE ANTI-E WAS EVIDENT. THERE WAS NO ADDITIONAL SAMPLE AVAILABLE FOR INVESTIGATION. THE CUSTOMER WAS REFERRED TO THE LIMITATION SECTION OF THE PACKAGE INSERT WHICH STATES THAT SPECIFICITIES OF PRESUMED SIGNIFICANCE, THAT ARE WHOLLY IGM IN NATURE (I.E. IGM ANTI-K OR IGM ANTI-E), MAY FAIL TO REACT IN THIS ASSAY.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-SCREEN (I AND II), LOT X384, ON THE GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258779 CAPTURE-R READY-SCREEN (I AND II) REAGENT RED BLOOD CELL KSZ IMMUCOR, INC. X384

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR