BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE II BLOOD LEAD TEST SYSTEM

    MDR report key: 8021068 · Received October 30, 2018

    Report

    Report Number
    1218996-2018-00018
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    September 9, 2013
    Report Date
    October 31, 2018
    Manufacturer
    MAGELLAN DIAGNOSTICS, INC.
    Product Code
    DOF
    UDI-DI
    00850355006017
    PMA / PMN Number
    K052549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEADCARE II BLOOD LEAD ANALYZER AND ADAPTER WAS RETURNED TO MAGELLAN FOR EVALUATION. DURING INVESTIGATIONAL TESTING, THE RETURNED UNIT WAS UNABLE TO POWER ON AND THE RETURNED ADAPTER WAS ABLE TO POWER ON MULTIPLE IN-HOUSE UNITS, THEREFORE THE FAILURE IS ATTRIBUTED TO THE ANALYZER. BECAUSE THE CUSTOMER INDICATED A BURNING SMELL 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 A BURNING ELECTRICAL SMELL COMING FROM THEIR LEADCARE II BLOOD LEAD ANALYZER WHEN PLUGGED INTO THE A/C ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861907 LEADCARE II BLOOD LEAD TEST SYSTEM LEADCARE II ANALYZER DOF MAGELLAN DIAGNOSTICS, INC. 00850355006017

    Patients

    Seq Age Sex Outcome Treatment
    1