BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE II BLOOD LEAD TEST SYSTEM

    MDR report key: 8027043 · Received October 31, 2018

    Report

    Report Number
    1218996-2018-00025
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    December 3, 2014
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYZER WAS RETURNED TO MAGELLAN FOR EVALUATION. DURING INVESTIGATIVE TESTING, MAGELLAN OBSERVED REPEATED FAILED EXTERNAL CONTROL TESTS. A REVIEW OF THE ANALYZER'S EVENT LOGS SHOWED THAT THE INSTRUMENT HAD GENERATED NUMEROUS ERROR MESSAGES OVER SEVERAL MONTHS WHILE IN USE AT THE USER FACILITY BUT THESE HAD NOT BEEN REPORTED TO MAGELLAN AS SPECIFIED IN PRODUCT LABELING. IN ADDITION, THE EVENT LOGS INDICATE THAT EXTERNAL QC WAS NOT CONSISTENTLY BEING PERFORMED ON A MONTHLY BASIS IN ACCORDANCE WITH LABEL INSTRUCTIONS. THERE HAVE BEEN NO REPORTS OF INJURIES BY 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

    A USER FACILITY CALLED MAGELLAN'S PRODUCT SUPPORT TO REPORT THEY WERE RECEIVING CONTROLS OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862741 LEADCARE II BLOOD LEAD TEST SYSTEM LEADCARE II ANALYZER DOF MAGELLAN DIAGNOSTICS, INC. 00850355006017

    Patients

    Seq Age Sex Outcome Treatment
    1