BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD CARE 2

    MDR report key: 22300433 · Received June 20, 2025

    Report

    Report Number
    MW5171703
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 30, 2025
    Report Date
    June 9, 2025
    Manufacturer
    MERIDIAN BIOSCIENCE, INC.
    Product Code
    DOF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SECTION E- LEAD CARE 2 DEVICE REPORTING ELEVATED LEAD. VENOUS. VENOUS DRAW 1.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837790 LEAD CARE 2 LEAD, ATOMIC ABSORPTION DOF MERIDIAN BIOSCIENCE, INC. 021225G

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Female