BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 2822181 · Received November 7, 2012

    Report

    Report Number
    1034569-2012-00208
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    August 31, 2012
    Report Date
    November 6, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGE RESULT FILES FROM THE NEO WERE REVIEWED BY AN IMMUCOR TECHNICAL SUPPORT SPECIALIST. INITIAL TESTING OF THE PRE-TRANSFUSION SAMPLE ((B)(4)) VISUALLY APPEARED NEGATIVE WITH CELLS 1 AND 3 OF THE SCREENING ASSAY AS REPORTED BY THE NEO. CELL 2 (E+, E-) RESULTED AS NEGATIVE AND IN COMPARISON TO CELLS 1 AND 3, VISUALLY APPEARED POSITIVE WITH A ROUGH, IRREGULAR SHAPED BUTTON AND PINK ADHERENCE IN THE BACKGROUND. A REVIEW OF THE RESULT FILES FROM THE ECHO SHOWED THAT PRE-TRANSFUSION AND POST-TRANSFUSION SAMPLES RESULTED AS NEGATIVE WITH CELLS 1 AND 3, AND POSITIVE (3+) WITH CELL 2 USING A DIFFERENT LOT OF INDICATOR CELLS. REACTIONS VISUALLY APPEARED AS REPORTED BY THE ECHO. BOTH SAMPLES WERE DAT POSITIVE. ANTIBODY IDENTIFICATION PANELS WERE PERFORMED AND AN ANTI-E WAS IDENTIFIED. NO ADDITIONAL SAMPLE WAS AVAILABLE FOR FURTHER INVESTIGATION AND THE PRODUCT HAD EXPIRED. THE CUSTOMER TESTED KNOWN POSITIVE AND NEGATIVE SAMPLES ON THE NEO. THE EXPECTED POSITIVE AND NEGATIVE RESULTS WERE OBTAINED. EXPIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS WITH THE 3-CELL SCREENING ASSAY ON THE GALILEO NEO INSTRUMENT WITH A PATIENT SAMPLE CONTAINING ANTI-E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY INDICATOR RED CELLS RED BLOOD CELLS KSZ IMMUCOR, INC. 221863

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other