BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISETYPE HEA MOLECULAR BEADCHIP TEST KIT

    MDR report key: 17435683 · Received August 1, 2023

    Report

    Report Number
    3005967741-2022-00003
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    October 3, 2022
    Report Date
    August 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED A POSSIBLE DISCREPANCY AS A SAMPLE TYPED FYA- AND UPON RETEST, THE SAME SAMPLE RESULTED IN FYA+. UPDATE 01AUG2023: THE NATURE OF THE HEALTH HAZARD IS CONSIDERED MEDIUM SINCE MULTIPLE FALSE-NEGATIVE RESULTS HAVE BEEN CONFIRMED. THE RISK COULD BE MITIGATED IF THE CUSTOMER IS AWARE OF THE DISCREPANT RESULTS AND CAN RERUN THE SAMPLES ON ANOTHER CARRIER. IN ADDITION, THESE FLIPPED CALLS OCCURRED ON DONOR SAMPLES, AND THERE IS NO RISK TO THE DONOR. ANY RECIPIENT WOULD BE TYPED AND CROSS-MATCHED TO THE DONOR.

    Description of Event or Problem · 0

    MULTIPLE FALSE NEGATIVE CALLS ON FYA. POSSIBLE DISCREPANCY AS A SAMPLE TYPED FYA- AND UPON RETEST, THE SAME SAMPLE RESULTED IN FYA+. UPDATE AS OF 01AUG2023: TRENDING ANALYSIS DETERMINED THIS IS THE ONLY COMPLAINT FOR THIS LOT 22-117-V OF THIS COMPLAINT NATURE, HOWEVER THE SECOND INSTANCE OF THE CUSTOMER REPORTING FALSE FYA(0) RESULTS WITHIN THE PAST YEAR. THE FALSE FYA(0) RESULTS ARE CAUSED BY THE SIGNIFICANT CHANGE IN THE FYA/FYB DELTA VALUES FOR SAMPLES THAT SHOULD RESULT AS FYA(+) AND IS DUE TO THE REDUCED REACTIVITY OF THE FYA BEADS RELATIVE TO THE FYB BEADS OF THE BEADCHIPS. THE UNDERLYING ROOT CAUSE OF THE REDUCED REACTIVITY IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342296 PRECISETYPE HEA MOLECULAR BEADCHIP TEST KIT MOLECULIAR ERYTHROCYTE TYPING TEST PEP BIOARRAY SOLUTIONS, LIMITED 800-20202-96 22-117-V 10888234102618

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown