BEUDAMED
    FDA Adverse Event Summary report: N

    LIFECODES LIFESCREEN DELUXE

    MDR report key: 6109745 · Received November 17, 2016

    Report

    Report Number
    2183608-2016-00006
    Date Received
    November 17, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 21, 2016
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    PMA / PMN Number
    BK160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ((B)(4)) RECEIVED ON 10/21/2016, WHERE CUSTOMER REPORTED UNEXPECTED NEGATIVE HLA CLASS I ANTIBODY RESULTS FOR 3 SAMPLES ((B)(6)) WITH LIFECODES LIFESCREEN DELUXE LOT 3003153.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760001 LIFECODES LIFESCREEN DELUXE LIFECODES LIFESCREEN DELUXE MZI IMMUCOR GTI DIAGNOSTICS, INC. NA 3003153

    Patients

    Seq Age Sex Outcome Treatment
    1