BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE II BLOOD LEAD TEST SYSTEM

    MDR report key: 8021136 · Received October 30, 2018

    Report

    Report Number
    1218996-2018-00020
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    May 8, 2014
    Report Date
    October 30, 2018
    Manufacturer
    MAGELLAN DIAGNOSTICS, INC.
    Product Code
    DOF
    UDI-DI
    00850355006017
    PMA / PMN Number
    K052549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY CONTACTED MAGELLAN'S PRODUCT SUPPORT TEAM TO REPORT THAT THEIR LEADCARE II BLOOD LEAD ANALYZER WOULD NO LONGER POWER ON. THE CUSTOMER INDICATED THE POWER CONNECTION TO THE ANALYZER HAD HEATED, AND WILL NO LONGER POWER ON. UNIT WAS RETURNED TO MAGELLAN FOR EVALUATION. DURING INVESTIGATIONAL TESTING THE UNIT WOULD NO LONGER POWER ON. BECAUSE THE CUSTOMER INDICATED HEATING AND THE RESULT WAS TOTAL POWER LOSS, THIS IS BEING REPORTED BECAUSE IT HAS THE POTENTIAL FOR THERMAL INJURY. NO REPORT OF INJURIES OR ERRONEOUS RESULTS FROM THE 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

    USER FACILITY CONTACTED MAGELLAN'S PRODUCT SUPPORT TEAM TO REPORT THAT THEIR LEADCARE II BLOOD LEAD ANALYZER WOULD NO LONGER POWER ON. THE CUSTOMER INDICATED THE POWER CONNECTION TO THE ANALYZER HAD HEATED, AND WILL NO LONGER POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862563 LEADCARE II BLOOD LEAD TEST SYSTEM LEADCARE II ANALYZER DOF MAGELLAN DIAGNOSTICS, INC. 00850355006017

    Patients

    Seq Age Sex Outcome Treatment
    1