BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISETYPE HEA MOLECULAR BEADCHIP TEST

    MDR report key: 15229190 · Received August 15, 2022

    Report

    Report Number
    3005967741-2022-00001
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 15, 2022
    Report Date
    August 15, 2022
    Manufacturer
    BIOARRAY SOLUTIONS, LIMITED
    Product Code
    PEP
    UDI-DI
    10888234100065
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED A POTENTIAL DISCREPANCY AS A SAMPLE TYPED E+ ONCE BY HEA AND E- TWICE BY HEA UPON RETEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238437 PRECISETYPE HEA MOLECULAR BEADCHIP TEST MOLECULIAR ERYTHROCYTE TYPING TEST PEP BIOARRAY SOLUTIONS, LIMITED 800-20202-08 22-31-V 10888234100065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown