BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEA 1.2 BEADCHIP KIT

    MDR report key: 21859450 · Received April 17, 2025

    Report

    Report Number
    3005967741-2025-00002
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 19, 2025
    Report Date
    July 17, 2025
    Manufacturer
    BIOARRAY SOLUTIONS LTD
    Product Code
    MAO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    CUSTOMER DESCRIPTION: MALE WHITE DONOR IS TESTED WITH HEA BEADCHIP AND SHOWS DISCREPANT RESULTS AT JKB. BIOARRAY EVENT DESCRIPTION: CUSTOMER, (B)(6) REPORTED THAT DONOR WAS TYPED JKB (NEG) WITH HEA1.2 BEADCHIP LOT 21-283-C IN 2022 AND THE DONOR WAS TYPED JKB (NEG) AGAIN WITH HEA 1.2 BEADCHIP LOT 24-046-C IN (B)(6) 2025. SEROLOGY WITH TWO DIFFERENT VENDORS AND FLUOGENE MOLECULAR TYPED JKB (+) IN (B)(6) 2025.

    Description of Event or Problem · 0

    CUSTOMER DESCRIPTION: MALE WHITE DONOR IS TESTED WITH HEA BEADCHIP AND SHOWS DISCREPANT RESULTS AT JKB. BIOARRAY EVENT DESCRIPTION: CUSTOMER, POLICLINICO MILAN REPORTED THAT DONOR WAS TYPED JKB (NEG) WITH HEA1.2 BEADCHIP LOT 21-283-C IN 2022 AND THE DONOR WAS TYPED JKB (NEG) AGAIN WITH HEA 1.2 BEADCHIP LOT 24-046-C IN JAN 2025. SEROLOGY WITH TWO DIFFERENT VENDORS AND FLUOGENE MOLECULAR TYPED JKB (+) IN (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733273 HEA 1.2 BEADCHIP KIT HEA 1.2 BEADCHIP KIT MAO BIOARRAY SOLUTIONS LTD 800-10202-08 24-046-C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male