BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISETYPE HEA MOLECULAR BEADCHIP KIT

    MDR report key: 16099354 · Received January 4, 2023

    Report

    Report Number
    3005967741-2022-00005
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    November 28, 2022
    Report Date
    January 4, 2023
    Manufacturer
    BIOARRAY SOLUTIONS, LIMITED
    Product Code
    PEP
    UDI-DI
    10888234102618
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE CUSTOMER REPORTED THAT TWO (2) FYA- DISCREPANCIES OCCURED WHILE TESTING WITH HEA LOT#22-141-V. THE CUSTOMER INFORMED BIOARRAY'S TECHNICAL SUPPORT SPECIALIST THAT SAMPLE (B)(4) TYPED FYA- ON PLATE HEAM5976_G3 AND TYPED FYA+ ON SLIDE HEAM0135_8. THIS WAS NOTICED AND RESULTS WERE NOT RELEASED HOWEVER SAMPLE (B)(4) ON PLATE HEAM5986_F8 RESULTED IN FYA-, BUT WAS ONLY DISCOVERED TO BE DISCORDANT WITH PREVIOUS TYPING PERFORMED AT NYBC ON PLATE HEAL4061_E11.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TWO (2) FYA- DISCREPANCIES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472300 PRECISETYPE HEA MOLECULAR BEADCHIP KIT MOLECULAR ERYTHROCYTE TYPING TEST PEP BIOARRAY SOLUTIONS, LIMITED 800-20202-96 22-141-V 10888234102618

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other