BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE II BLOOD LEAD TEST SYSTEM

    MDR report key: 8027063 · Received October 31, 2018

    Report

    Report Number
    1218996-2018-00028
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    June 6, 2014
    Report Date
    October 31, 2018
    Manufacturer
    MAGELLAN DIAGNOSTICS, INC.
    Product Code
    DOF
    UDI-DI
    00850355006000
    PMA / PMN Number
    K052549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY CONTACTED MAGELLAN'S PRODUCT SUPPORT TEAM TO REPORT THEIR TREATMENT REAGENT VIALS FROM THEIR LEADCARE II BLOOD LEAD TEST KIT WERE UNDER FILLED. USER'S TEST KIT WAS SENT TO MAGELLAN FOR EVALUATION. DURING INVESTIGATIONAL TESTING IT WAS NOTED THAT TREATMENT REAGENT VIALS WERE OUT OF SPECIFICATION FOR FILLING. NO REPORTS OF INJURIES FROM USER FACILITY. NOTE: LATE FILING IS PART OF MAGELLAN DIAGNOSTICS, INC. RESPONSE TO FDA'S 483 ISSUED ON (B)(4) 2017. (B)(4). CUSTOMER COMPLAINT: (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY CALLED MAGELLAN'S PRODUCT SUPPORT TO REPORT THE REAGENT VIAL ONLY HAD A SMALL DROP OF THE TREATMENT REAGENT, WHICH IS NOT ENOUGH TO ESTABLISH THE CORRECT REAGENT TO BLOOD RATIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862775 LEADCARE II BLOOD LEAD TEST SYSTEM LEADCARE® II BLOOD LEAD TEST KIT DOF MAGELLAN DIAGNOSTICS, INC. 1401A 00850355006000

    Patients

    Seq Age Sex Outcome Treatment
    1