BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE II BLOOD LEAD TEST SYSTEM

    MDR report key: 8027055 · Received October 31, 2018

    Report

    Report Number
    1218996-2018-00027
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    November 26, 2012
    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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY CONTACTED MAGELLAN'S PRODUCT SUPPORT TEAM TO REPORT THAT WHEN REMOVING BATTERIES FROM THEIR LEADCARE II BLOOD LEAD ANALYZER THEY WERE EXTREMELY HOT TO THE TOUCH. CUSTOMER STATED THE BATTERIES WERE INSTALLED PROPERLY. UNIT WAS RETURNED TO MAGELLAN FOR EVALUATION. DURING INVESTIGATIVE TESTING, THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. 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

    USER FACILITY CONTACTED MAGELLAN'S PRODUCT SUPPORT TEAM TO REPORT TWO OF THE BATTERIES WERE EXTREMELY HOT WHEN REMOVED FROM THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862761 LEADCARE II BLOOD LEAD TEST SYSTEM LEADCARE II ANALYZER DOF MAGELLAN DIAGNOSTICS, INC. 00850355006017

    Patients

    Seq Age Sex Outcome Treatment
    1