BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE II BLOOD LEAD TEST SYSTEM

    MDR report key: 8027033 · Received October 31, 2018

    Report

    Report Number
    1218996-2018-00024
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    July 23, 2012
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY CALLED MAGELLAN'S PRODUCT SUPPORT TEAM TO REPORT DISCREPANT PATIENT RESULTS. A PEDIATRIC PATIENT TESTED ON THE LEADCARE II BLOOD LEAD TESTING SYSTEM AND GAVE A RESULT OF 46.3 UG/DL, CONFIRMATION TESTING RESULT WAS 59 UG/DL. THE TEST KIT WAS NOT RETURNED FOR EVALUATION THEREFORE THE CAUSE OF THE FAILURE CAN NOT BE DETERMINED. NO REPORTED HARM OR INJURIES OCCURRED AS A RESULT OF THIS ISSUE. 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 CALLED MAGELLAN'S PRODUCT SUPPORT TEAM TO REPORT DISCREPANT PATIENT RESULTS. A PEDIATRIC PATIENT TESTED ON THE LEADCARE II BLOOD LEAD TESTING SYSTEM AND GAVE A RESULT OF 46.3 UG/DL, CONFIRMATION TESTING RESULT WAS 59 UG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862678 LEADCARE II BLOOD LEAD TEST SYSTEM LEADCARE II ANALYZER DOF MAGELLAN DIAGNOSTICS, INC. 00850355006000

    Patients

    Seq Age Sex Outcome Treatment
    1