BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISETYPE HEA MOLECULAR BEADCHIP KIT

    MDR report key: 16080734 · Received December 30, 2022

    Report

    Report Number
    3005967741-2022-00004
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    October 13, 2022
    Report Date
    April 17, 2023
    Manufacturer
    BIOARRAY SOLUTIONS, LIMITED
    Product Code
    PEP
    UDI-DI
    10888234102618
    PMA / PMN Number
    BP130026
    Removal / Correction Number
    3005967741-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOW SIGNAL (LS) AND INDETERMINED CALL (IC) WARNINGS DUE TO CHIP TO CHIP VARIATION WITH LOCATION SPECIFIC WEAK SIGNAL.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TWO RUN FAILURES. LOW SIGNAL (LS) AND INDETERMINED CALL (IC) WARNINGS.

    Description of Event or Problem · 0

    (B)(6) REPORTED THAT DURING THEIR IN-COMING QUALITY TESTING THERE WERE TWO RUN FAILURES DUE TO INVALID CONTROLS AS WELL AS MULTIPLE SAMPLE FAILURES DURING THESE RUN FAILURES. THE INVALID REF-PA AND/OR REF-PB AS WELL AS MULTIPLE SAMPLE FAILURE RESULTS WERE OBSERVED ACROSS THREE PLATE IDS HEAM4137 HEAM4138 AND HEAM4154 WHILE TESTING WITH THE HEA ASSAY LOT# 22-99-V. THE CUSTOMER IN-COMING QUALITY TESTING FAILED FOR HEA PLATE LOT# 22-99-V DUE TO HIGH FREQUENCY OF INVALID SAMPLES. BIOARRAY COMPLETED IN-HOUSE TESTING OF THE CUSTOMER'S RETURNED PCR PRODUCT WITH OUR QA RETAIN KIT HEAM4143 FOR HEA LOT# 22-99-V. THE PLATE EXHIBITED POOR PERFORMANCE AND BIOARRAY REPLICATED THE INVALID POSITIVE CONTROLS AS WELL AS THE MULTIPLE SAMPLE FAILURES. THE NO TYPE DETERMINED (NTD) CHIPS ARE DUE TO WEAK ASSAY SIGNAL ON THE THREE ALLEGED PLATES AND ON ONE OF THE INVESTIGATION PLATES. THERE WERE HIGH SIGNAL INTENSITY PROBES AND WEAK PROBES ON THE NTD CHIPS, WHICH SUGGEST THE WEAK SIGNAL IS NOT DUE TO SURFACE BLOCKAGE, INHIBITION OF EMAP REACTION, AND PROBE INACTIVATION. WEAK ASSAY SIGNAL IS UNRELATED TO BSA COATING ON THE BEADS. ASSAY SIGNAL FROM THE WEAK SIGNAL PROBES COULD NOT BE FULLY RECOVERED IN THE RE-ASSAY, WHICH SUGGEST THE WEAK SIGNAL IS DUE TO LOSS OF THE PROBES ON THE BEAD SURFACE. THE HEA LOT# 22-99-V WAS RECALLED. THE CUSTOMER NOTIFICATION WAS COMMUNICATED TO COMMUNITY BLOOD CENTRE-KANSAS CITY ON THE DECISION AND DISPOSITION OF THE RECALL LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2353869 PRECISETYPE HEA MOLECULAR BEADCHIP KIT MOLECULIAR ERYTHROCYTE TYPING TEST PEP BIOARRAY SOLUTIONS, LIMITED 800-20202-96 22-99-V 10888234102618

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other