BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SRCEEN 3

    MDR report key: 2418632 · Received January 17, 2012

    Report

    Report Number
    1034569-2012-00010
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    December 22, 2011
    Report Date
    January 17, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE RESULTS FILES FOR BATCH 9549 SHOWS A WELL SCORE OF 1 & 2 RESPECTIVELY FOR CELLS I & III FOR CRRS(3), LOT R176 RESULTING IN A NEGATIVE REACTION. CELL I IS A HETEROZYGOUS JKA CELL AND CELL III IS A HOMOZGOUS JKA CELL. RESULTS SHOULD BE POSITIVE. SAMPLE CONTAINS ANTI-JKA. WELL IMAGES APPEAR NEGATIVE. THE PRODUCT WAS EXPIRED WHEN THE COMPLAINT CAM IN. NO PRODUCT TESTING CAN BE PERFORMED. A REVIEW OF THE DHR: MASTER LIST STATES CELL I AN III JK(A+). BULK TESTING: BOTH CELLS 2+ (CONTROL = 3+ LOT 614007-1). MANUFACTURING DRY PLATE: CELL I = 8, CELL III = 9-10 (LOT DL17024). PRODUCT WAS APPROVED FOR RELEASE INTO FINISHED GOODS ON 19SEP2011.

    Description of Event or Problem · 1

    CUSTOMER REPORTED GETTING UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-SCREEN 3 (CRRS3) LOT 176, WHEN TESTING A PATIENT SAMPLE CONTAINING ANTI-JKA ON THE ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SRCEEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R176

    Patients

    Seq Age Sex Outcome Treatment
    1