BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1406337 · Received June 24, 2009

    Report

    Report Number
    1034569-2009-00206
    Event Type
    Malfunction
    Date Received
    June 24, 2009
    Date of Event
    June 2, 2009
    Report Date
    June 18, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE FYA AND K ANTIGENS WERE CONFIRMED ON CRRID, LOT ID115. TESTING WAS PERFORMED WITH THE CUSTOMER'S RETURNED PATIENT SAMPLE (HISTORY OF ANTI-K AND ANTI-FYA) USING RETENTION CRRID, LOT ID115 ON AN IN-HOUSE ECHO. SAMPLE EXHIBITED 2+ REACTIVITY WITH K+ CELLS AND WAS NONREACTIVE WITH ALL OTHER CELLS. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH THE CUSTOMER'S SAMPLE USING SELECTED FY(A+B+), FY(A+B-), AND FY(A-) CELLS FROM RETENTION PANOCELL-16, LOT 18413. IMMUADD, LOT 705003-1 WAS USED AS POTENTIATOR. THE SAMPLE WAS NONREACTIVE WITH ALL CELLS. THE EVENT APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE TESTED WITH CAPTURE-R READY ID (CRRID LOT ID115 ON THE ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR