BEUDAMED
    FDA Adverse Event Summary report: N

    LIFECODES LIFESCREEN DELUXE

    MDR report key: 6104640 · Received November 15, 2016

    Report

    Report Number
    2183608-2016-00005
    Date Received
    November 15, 2016
    Date of Event
    June 9, 2016
    Report Date
    October 17, 2016
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    PMA / PMN Number
    BK160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ((B)(4)) RECEIVED ON 10/17/2016, WHERE CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULT FOR HLA CLASS I ANTIBODY WITH LIFECODES LIFESCREEN DELUXE (LMX) LOT 3003153, FOR THE ASSAY RUN ON (B)(6) 2016. THE CUSTOMER REPORTED THAT THERE WAS AN IMPACT ON PATIENT CARE, AS THEY COULD NOT MAKE THE APPROPRIATE DECISIONS FOR THIS PATIENT, AS THEY COULD NOT CONFIRM THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752688 LIFECODES LIFESCREEN DELUXE LIFECODES LIFESCREEN DELUXE MZI IMMUCOR GTI DIAGNOSTICS, INC. NA 3003153

    Patients

    Seq Age Sex Outcome Treatment
    1