BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD ANALYZER SYSTEM

    MDR report key: 8027098 · Received October 31, 2018

    Report

    Report Number
    1218996-2018-00033
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    August 17, 2011
    Report Date
    October 31, 2018
    Manufacturer
    MAGELLAN DIAGNOSTICS, INC.
    Product Code
    DOF
    UDI-DI
    00850355006017
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY CONTACTED MAGELLAN'S PRODUCT SUPPORT TEAM TO REPORT A BURNING SMELL WAS COMING FROM THEIR 3010B BLOOD LEAD ANALYZER. THE CUSTOMER THEN PROCEEDED TO REPLACE THE MOTOR ON THEIR UNIT WHICH RESOLVED THE ISSUE. NO REPORTS OF INJURIES 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 LEAD ANALYZER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862903 LEAD ANALYZER SYSTEM LEAD ANALYZER SYSTEM (PRE-AMENDMENT) DOF MAGELLAN DIAGNOSTICS, INC. 00850355006017

    Patients

    Seq Age Sex Outcome Treatment
    1