BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN I AND II

    MDR report key: 1901916 · Received November 18, 2010

    Report

    Report Number
    1034569-2010-00248
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 18, 2010
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMED PHENOTYPING BY MANUAL METHOD USING RETENTION PRODUCTS FROM THE SAME LOT USED BY CUSTOMER AND ANTI-LEB BLOOD GROUPING REAGENT. ALL REAGENT RED BLOOD CELLS EXHIBITED THE EXPECTED REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. THE CUSTOMER DID NOT RETURN PRODUCT OR SUBMIT PATIENT SAMPLE FOR EVALUATION. IT IS STATED IN THE CAPTURE-R READY SCREEN PACKAGE INSERTS THAT "CAPTURE IS INTENDED FOR USE IN THE IDENTIFICATION OF UNEXPECTED IGG ANTIBODIES TO RED BLOOD CELLS BY MANUAL, SEMI-AUTOMATED, AND AUTOMATED METHODS". LE(B) IS AN IGM ANTIBODY. NO PRODUCT DEFICIENCIES WERE IDENTIFIED. PRODUCT IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WITH THE CAPTURE-R READY SCREEN I/II ASSAY ON THE GALILEO INSTRUMENT, AND THAT A PATIENT EXPERIENCED AN ACUTE HEMOLYTIC TRANSFUSION REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN I AND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X324

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other