BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISETYPE HEA MOLECULAR BEADCHIP KIT

    MDR report key: 18503916 · Received January 12, 2024

    Report

    Report Number
    3005967741-2024-00001
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    December 13, 2023
    Report Date
    August 16, 2024
    Manufacturer
    BIOARRAY SOLUTIONS, LTD.
    Product Code
    PEP
    UDI-DI
    10888234100065
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR WAS FILED ON 12JAN2024; FOLLOW UP 001 WAS FILED ON 07MAR2024; FOLLOW UP 002 WAS FILED ON 16AUG2024.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ABOUT JKB DISCREPANCY. CUSTOMER STATED PATIENT RESULT IS JK(B-) ON PRECISETYPE HEA BEADCHIP KIT AND A DIFFERENT MOLECULAR PLATFORM. SAME SAMPLE TESTS JK(B+) WITH TWO SEROLOGIC TESTS.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ABOUT JKB DISCREPANCY. CUSTOMER STATED PATIENT RESULT IS JK(B-) ON PRECISETYPE HEA BEADCHIP KIT AND A DIFFERENT MOLECULAR PLATFORM. SAME SAMPLE TESTS JK(B+) WITH TWO SEROLOGIC TESTS.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ABOUT JKB DISCREPANCY. CUSTOMER STATED PATIENT RESULT IS JK(B-) ON PRECISETYPE HEA BEADCHIP KIT AND A DIFFERENT MOLECULAR PLATFORM. SAME SAMPLE TESTS JK(B+) WITH TWO SEROLOGIC TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057092 PRECISETYPE HEA MOLECULAR BEADCHIP KIT PRECISE TYPE HEA BEADCHIP KIT PEP BIOARRAY SOLUTIONS, LTD. 800-20202-08 23-162-V 10888234100065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown