BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEA 1.2 BEADCHIP KIT, SLIDE CE

    MDR report key: 4350693 · Received December 22, 2014

    Report

    Report Number
    3005967741-2014-00004
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    December 2, 2014
    Report Date
    December 22, 2014
    Manufacturer
    BIOARRAY SOLUTIONS LTD.
    Product Code
    PEP
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    12/02/2014 - THE SAMPLE NEEDS TO BE TESTED ON THE RHCE KIT AND IF NO VARIANTS ARE DETECTED, IT WILL BE SENT FOR SEQUENCING. 12/22/2014 - SEQUENCING RESULTS NOT READY. FOLLOW-UP REPORT WILL BE SENT ONCE SEQUENCING RESULTS ARE READY, 30 CALENDAR DAYS FROM DATE OF SUBMISSION OF MDR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO TECHNICAL SPECIALIST THAT A DONOR SAMPLE TYPED C+ BY SEROLOGY AND C- BY HEA BEADCHIP. THE MOLECULAR RESULT HAS BEEN CONFIRMED BY A SECOND MOLECULAR TEST (IDCOREXT, GRIFOLS/PROGENIKA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842749 HEA 1.2 BEADCHIP KIT, SLIDE CE HEA 1.2 BEADCHIP KIT, SLIDE CE PEP BIOARRAY SOLUTIONS LTD. 800-10202-08 14-1

    Patients

    Seq Age Sex Outcome Treatment
    1