BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN (3)

    MDR report key: 2483742 · Received March 8, 2012

    Report

    Report Number
    1034569-2012-00041
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    February 7, 2012
    Report Date
    March 7, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS: BOTH SCREENS RESULTED NEGATIVE IN ALL WELLS. WELL 1 IS C HOMOZYGOUS POSITIVE IN BOTH LOT NUMBERS, WELLS 2 AND 3 ARE C NEGATIVE. REACTION SCORE FOR WELL 1 LOT R195 IS 2, VISUALLY IT IS SLIGHTLY POSITIVE WITH SLIGHT ADHERENCE IN THE WELL AND A SLIGHTLY FUZZY BUTTON. REACTION SCORE FOR WELL 1 LOT R205 IS 1, VISUALLY IT IS NEGATIVE. PERFORMED A SCREEN ASSAY ON FOUR KNOWN NEGATIVE IN HOUSE DONORS ON THE ECHO USING CAPTURE-R READY-SCREEN-3, LOT R195, R205 AND CAPTURE-R READY INDICATOR RED CELLS, LOT 221787. CONTROLS PERFORMED AS EXPECTED AND ALL IN HOUSE DONORS RESULTED AS NEGATIVE. RETENTION PRODUCTS PERFORMED AS EXPECTED. CONFIRMED THE REACTIVITY OF THE C ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN 3, LOTS R195 AND R205 USING RETENTION CAPTURE-R READY INDICATOR RED CELLS LOT 221784 AND ANTI-C, LOT 6D420 (1:250). CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. RETENTION PRODUCTS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN UNEXPECTED NEGATIVE REACTION WHEN TESTING A SAMPLE WITH A KNOWN ANTI-C WITH CAPTURE-R READY SCREEN 3 (CRRS 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R195

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR