BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE II BLOOD LEAD TEST SYSTEM

    MDR report key: 9199244 · Received October 16, 2019

    Report

    Report Number
    1218996-2019-00034
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    June 3, 2019
    Report Date
    October 16, 2019
    Manufacturer
    MAGELLAN DIAGNOSTICS, INC.
    Product Code
    DOF
    UDI-DI
    00850355006017
    PMA / PMN Number
    K052549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY FIRST CONTACTED MAGELLAN'S PRODUCT SUPPORT TEAM TO REPORT THAT THEY ENCOUNTERED AN <3.3 UG/DL RESULT FOR PATIENT #1 (REFERENCE LAB RESULT WAS 10-12 UG/DL) ON INSTRUMENT S/N: (B)(4). THE ANALYZER AND AC ADAPTOR WERE RETURNED TO MAGELLAN FOR EVALUATION. MAGELLAN COULD NOT REPLICATE THE SUPPRESSION REPORTED BY THE USER FACILITY, THEREFORE, THE COMPLAINT COULD NOT BE VERIFIED. DURING THE INVESTIGATION MAGELLAN CONFIRMED THE USER FACILITY WAS NOT RUNNING CONTROLS PER THE PRODUCT LABELING. BECAUSE THE COMPLAINT COULD NOT BE CONFIRMED, AND CONTROLS WERE NOT BEING RUN APPROPRIATELY THE PRODUCT SUPPORT TEAM WAS UNABLE TO DETERMINE A CAUSE. NO USER OR PATIENT IMPACT OR HARM WAS REPORTED. LATE FILING IS PART OF MAGELLAN DIAGNOSTICS, INC. RESPONSE TO FDA'S REQUEST ISSUED ON (B)(6) 2019. MAG-CC-00515 ORIGINAL CASE (CLOSED (B)(6) 2019). MAG-CC-00931 NEW CASE (OPENED TO ADDRESS MDR).

    Description of Event or Problem · 1

    USER FACILITY FIRST CONTACTED MAGELLAN'S PRODUCT SUPPORT TEAM TO REPORT THEY ENCOUNTERED A SUPPRESSED PATIENT RESULTS ON LEADCARE II BLOOD LEAD ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993532 LEADCARE II BLOOD LEAD TEST SYSTEM LEADCARE II ANALYZER DOF MAGELLAN DIAGNOSTICS, INC. 70-6529-P 00850355006017

    Patients

    Seq Age Sex Outcome Treatment
    1