BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1050163 · Received May 27, 2008

    Report

    Report Number
    1034569-2008-00156
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 14, 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

    REACTIVITY OF THE K ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN, LOT R022 AND CAPTURE-R READY ID, LOT ID099. REACTIVITY OF THE E ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN LOT R022. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE- R READY SCREEN(3), LOT #R022, EXP. 6/10/08 WHEN TESTING A PATIENT SAMPLE CONTAINING A PREVIOUSLY IDENTIFIED ANTI-K AND ANTI-E ON THE ECHO. NO ADVERSE REACTIONS OCCURRED AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. M00147

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR