BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-S

    MDR report key: 1226185 · Received November 13, 2008

    Report

    Report Number
    1034569-2008-00553
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 7, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    GMQ
    PMA / PMN Number
    BK950017
    Removal / Correction Number
    06-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION DETERMINED THAT THE CUSTOMER USED A LOT OF CAPTURE-S INDICATOR CELLS TO PERFORM TESTING THAT HAD BEEN THE SUBJECT OF A RECALL. IN-HOUSE TESTING DEMONSTRATED THAT 4 OF THE 7 SAMPLES WERE REACTIVE WITH THE CAPTURE-S ASSAY. THE ORIGINAL TESTING WAS PERFORMED WITH THE OLYMPUS PK TP ASSAY, WHICH IS A TREPONEMAL ANTIGEN BASED ASSAY AND 3 OF THOSE SAMPLES WERE RPR REACTIVE; THE RPR IS A NONTREPONEMAL BASED ASSAY FOR SYPHILIS. CAPTURE-S IS A NONTREPONEMAL ANTIGEN BASED ASSAY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SEVEN KNOWN SYPHILIS POSITIVE SAMPLES WERE NONREACTIVE ON THE GALILEO WITH THE CAPTURE-S ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-S NONTREPONEMAL SYPHILIS TEST GMQ IMMUCOR, INC. 299018

    Patients

    Seq Age Sex Outcome Treatment
    1