BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 1572052 · Received January 8, 2010

    Report

    Report Number
    1034569-2010-00004
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    December 9, 2009
    Report Date
    January 7, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIRMED THE REACTIVITY OF THE FYA ANTIGEN ON RETENTION CRRS (3) LOT R067 AND CRRID LOT ID121 WITH ANTI-FYA USING CAPTURE-R READY INDICATOR CELLS, LOT 221438. THESE ARE THE LOTS OF REAGENTS USED BY THE CUSTOMER. MANUAL CAPTURE PERFORMED WITH CUSTOMER'S PATIENT SAMPLE USING FY(A+) CELLS FROM RETENTION CRRID, LOT ID121, AND CRRS (3), LOT R067. SAMPLE WAS NONREACTIVE WITH ALL FY(A+) CELLS. HEMAGGLUTINATION TUBE TESTING PERFORMED WITH CUSTOMER'S PATIENT SAMPLE USING SELECTED FY(A+B+), FY(A+B-), AND FY(A-) CELLS FROM RETENTION PANOCELL-10. SAMPLE EXHIBITED +W REACTIVITY WITH FY(A+B-) CELL, MICROSCOPIC WEAK REACTIVITY WITH FY(A+B+), AND WAS NONREACTIVE WITH FY(A-) CELL. THE NATURE OF THE SAMPLE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WHEN TESTING A PATIENT SAMPLE WITH CAPTURE -R READY SCREEN (CRRS) AND CAPTURE-R READY ID (CRRID).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR R067

    Patients

    Seq Age Sex Outcome Treatment
    1