BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1003366 · Received February 28, 2008

    Report

    Report Number
    1034569-2008-00055
    Event Type
    Malfunction
    Date Received
    February 28, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 26, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESIDUAL VOLUME, WASHER DISPENSE ACCURACY, AND PROBE ACCURACY RESULTS WERE WITHIN RANGE. CAMERA IMAGES APPEARED OPTIMAL. INSTRUMENT IMAGES WERE RETRIEVED;CELLS #1, 3, 6, 9 AND 12 ON CAPTURE-R READY-ID, LOT 096 ARE HOMOZYGOUS JKA CELLS, BUT RESULTED AS NEGATIVE. CELL #10 IS A HETEROZYGOUS JKA CELL THAT RESULTED NEGATIVE ALSO. THE REACTIONS VISUALLY LOOKED POSITIVE(1+). THE PRODUCT HAD EXPIRED PRIOR TO RECEIVING THE COMPLAINT; THEREFORE, NO ADDITIONAL SEROLOGICAL TESTING WAS PERFORMED. THE PRESENCE OF THE JKA ANTIGEN ON CRRID, LOT ID096, WAS VERIFIED THROUGH LOT RELEASE RECORDS. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CRRID, LOT ID096 WHEN TESTING A PATIENT SAMPLE CONTAINING ANTI-JKA ON THE ECHO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1