BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 2029781 · Received March 25, 2011

    Report

    Report Number
    1034569-2011-00036
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 25, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF IMAGES SHOWS SAMPLE RESULTED AS NEGATIVE FOR ALL SCREENING CELLS 1-3. IMAGES OF SCREENING CELLS APPEAR NEGATIVE. CUSTOMER REPORTED REPEATING THE SCREEN ASSAY WITH A NEW LOT OF CAPTURE-R READY INDICATOR RED CELLS (CRRIC), LOT 221643. SAMPLE SHOWED EXPECTED REACTIVITY WITH THE NEW LOT OF CRRIC WITH THE SAME POSITIVE TEST RESULTS AS THE OTHER FACILITY. CANNOT RULE OUT THAT CRRIC MAY HAVE BEEN COMPROMISED AND CAUSED THE UNEXPECTED NEGATIVE RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A SAMPLE WITH CAPTURE-R READY SCREEN (CRRS) 3 ON THE ECHO. THE SAMPLE WAS TESTED AT A DIFFERENT FACILITY AND AN ANTI-D WAS DETECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR