BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGELLAN LEAD TEST

    MDR report key: 12638864 · Received October 14, 2021

    Report

    Report Number
    MW5104648
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    May 19, 2021
    Report Date
    October 12, 2021
    Manufacturer
    MAGELLAN DIABNOSTICS, INC.
    Product Code
    DOF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY BABY TOOK A LEAD TEST THAT WAS NORMAL ON (B)(6) 2021. THE RECALL LED TO A RETEST AND HER LEVELS WERE ELEVATED. WE NOW HAVE NO IDEA IF THEY WERE ELEVATED BACK IN (B)(6) WHICH MEANS 6 MONTHS OF POTENTIAL HARM DUE TO THE FAILED TEST. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528046 MAGELLAN LEAD TEST LEAD, ATOMIC ABSORPTION DOF MAGELLAN DIABNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention