BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISETYPE HEA 1.2 BEADCHIP KIT, SLIDE

    MDR report key: 6321811 · Received February 10, 2017

    Report

    Report Number
    3005967741-2017-00005
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    January 12, 2017
    Report Date
    February 10, 2017
    Manufacturer
    BIOARRAY SOLUTIONS LTD.
    Product Code
    PEP
    UDI-DI
    10888234100065
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS N- USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE N+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106365 PRECISETYPE HEA 1.2 BEADCHIP KIT, SLIDE PRECISETYPE HEA 1.2 BEADCHIP KIT, SLIDE PEP BIOARRAY SOLUTIONS LTD. 800-10202-08 16-320-V 10888234100065

    Patients

    Seq Age Sex Outcome Treatment
    1