BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1003370 · Received February 28, 2008

    Report

    Report Number
    1034569-2008-00049
    Event Type
    Malfunction
    Date Received
    February 28, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 20, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENCE OF THE K AND FYA ANTIGENS WERE CONFIRMED ON RETENTION CAPTURE-R READY-ID, LOT ID096. THE CUSTOMER DID NOT SENT SAMPLES FOR TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CRRID ON THE ECHO. ANTI-K WAS IDENTIFIED ON ECHO (CELLS 8 AND 14 WERE BOTH 4+) ON A PATIENT SAMPLE. THE SAMPLE WAS REPEATED MANUALLY IN GEL AND IDENTIFIED ANTI-K AND ANTI-FYA. THE ANTI-FYA WAS VERY WEAK.

    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 40 YR