BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEADCARE

    MDR report key: 13309794 · Received January 20, 2022

    Report

    Report Number
    1218996-2022-00001
    Event Type
    Injury
    Date Received
    January 20, 2022
    Date of Event
    May 19, 2021
    Report Date
    January 20, 2022
    Manufacturer
    MAGELLAN DIAGNOSTICS INC
    Product Code
    DOF
    PMA / PMN Number
    K052549
    Removal / Correction Number
    RES-87992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FDA'S MEDICAL DEVICE REPORTING (MDR) TEAM SENT THIS ADVERSE EVENT REPORT TO MAGELLAN DIAGNOSTICS, INC. WITH A COVER LETTER DATED DECEMBER 7, 2021. THE EVENT WAS REPORTED IN MEDWATCH REPORT MW5104648 AS HAVING OCCURRED ON (B)(6) 2021 AND MAGELLAN IS FILING THIS MDR AS A REPORT OF A POTENTIAL FALSE NEGATIVE RESULT ASSOCIATED WITH THE LEADCARE II DEVICE AND RECALL Z-1952-2021 (RES-87992).

    Description of Event or Problem · 0

    THE FOLLOWING NARRATIVE IS BASED ON MEDWATCH REPORT MW5104648: "MY BABY TOOK A LEAD TEST THAT WAS NORMAL ON (B)(6) 2021. THE RECALL LEAD 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
    519953 LEADCARE LEADCARE II DOF MAGELLAN DIAGNOSTICS INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention