BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (I AND II)

    MDR report key: 4161952 · Received October 10, 2014

    Report

    Report Number
    1034569-2014-00180
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 10, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/0.0
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELLS ON (B)(4) 2014. THE IMMUCOR LABORATORY WAS UNABLE TO TEST RETENTION PRODUCT BECAUSE THE LEA ANTIGEN IS NOT A SPECIFICATION TO BE CONFIRMED FOR FINAL PRODUCT RELEASE. THE IMMUCOR LABORATORY DID HOWEVER TEST RETURNED CUSTOMER BLOOD SAMPLES ON (B)(4) 2014, (B)(4) 2014 AND (B)(4) 2014, AND THE CUSTOMER UNEXPECTED NEGATIVE RESULTS WERE DUPLICATED BY CAPTURE TESTING ON GALILEO NEO. ADDITIONALLY, THE EXPECTED CUSTOMER POSITIVE RESULTS BY TUBE TESTING WERE ALSO DUPLICATED AS POSITIVE. AN IMMUCOR FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE ON (B)(4) 2014 AND FOUND THE INSTRUMENT TO BE OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (I AND II) USING A GALILEO NEO INSTRUMENT WHICH RESULTED IN AN ACUTE HEMOLYTIC TRANSFUSION REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644237 CAPTURE-R READY-SCREEN (I AND II) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X412

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other