BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE II BLOOD LEAD TEST SYSTEM

    MDR report key: 8027128 · Received November 1, 2018

    Report

    Report Number
    1218996-2018-00039
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    February 1, 2011
    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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INVESTIGATIVE TESTING, MAGELLAN OBSERVED THE CAPILLARY TUBES WERE FILLING BEYOND THE BLACK LINE. BECAUSE THIS MEASUREMENT IS CRITICAL TO THE ASSAY PERFORMANCE, THIS HAS A RISK OF DELIVERING ERRONEOUS RESULTS. NO REPORTS OF INJURY OR ERRONEOUS RESULTS HAVE BEEN REPORTED. 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 THE CAPILLARY TUBES ARE FILLING HIGHER THAN THE BLACK LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867955 LEADCARE II BLOOD LEAD TEST SYSTEM LEADCARE® II BLOOD LEAD TEST KIT DOF MAGELLAN DIAGNOSTICS, INC. 1009A 00850355006000

    Patients

    Seq Age Sex Outcome Treatment
    1