BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEA 1.2 BEADCHIP KIT, SLIDE CE

    MDR report key: 5332175 · Received December 29, 2015

    Report

    Report Number
    3005967741-2015-00016
    Event Type
    Malfunction
    Date Received
    December 29, 2015
    Date of Event
    December 4, 2015
    Report Date
    December 28, 2015
    Manufacturer
    BIOARRAY SOLUTIONS LTD.
    Product Code
    PEP
    UDI-DI
    10888234100065
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DONOR TYPED BIG C+ BY HEA BEADCHIP AND BIG C- BY SEROLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856775 HEA 1.2 BEADCHIP KIT, SLIDE CE HEA 1.2 BEADCHIP KIT, SLIDE CE PEP BIOARRAY SOLUTIONS LTD. 800-10202-08 14-84 10888234100065

    Patients

    Seq Age Sex Outcome Treatment
    1