BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE II BLOOD LEAD TEST SYSTEM

    MDR report key: 8027124 · Received November 1, 2018

    Report

    Report Number
    1218996-2018-00038
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    September 21, 2010
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A USER FACILITY CALLED MAGELLAN'S PRODUCT SUPPORT ON TO REPORT USED SENSOR ERROR MESSAGES ON THEIR LEADCARE II BLOOD LEAD ANALYZER. TESTING OF THE RETURNED UNIT AT MAGELLAN REPLICATED ERROR MESSAGES, AND PRODUCE QC RESULTS THAT WERE OUT OF RANGE. NO REPORTED HARM OR INJURIES OCCURRED AS A RESULT OF THIS ISSUE. CORROSION WAS NOTED ON SENSOR PINS. CORROSION OF THE SENSOR PINS OCCURS WHEN THERE IS OVEREXPOSURE OF THE ANALYZER PINS TO THE ASSAY'S ACIDIC TREATMENT REAGENT. THIS OCCURS WHEN USED TEST SENSORS ARE NOT REMOVED IMMEDIATELY AFTER TESTING (PER INSTRUMENT INSTRUCTIONS) OR WHEN TOO MUCH SAMPLE IS ADDED TO THE TEST SENSOR. PERIODIC TESTING WITH BLOOD LEAD QC CONTROLS IS USED TO MONITOR ANALYZER PERFORMANCE. MAGELLAN PROVIDED THE CUSTOMER WITH A NEW INSTRUMENT, ADDITIONAL TRAINING, SENT THEM NOTIFICATIONS. NO FURTHER ISSUES OF THIS NATURE HAVE BEEN SHOWN FOR THIS CUSTOMER. 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 ON TO REPORT USED SENSOR ERROR MESSAGES ON THEIR LEADCARE II BLOOD LEAD ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867942 LEADCARE II BLOOD LEAD TEST SYSTEM LEADCARE II ANALYZER DOF MAGELLAN DIAGNOSTICS, INC. 00850355006017

    Patients

    Seq Age Sex Outcome Treatment
    1