BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT MMT-1762KCN 670G V4.11 CAN MM

    MDR report key: 8665540 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-11009
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 4, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000216481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A CRITICAL PUMP ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 8.6 MMOL/L. CUSTOMER REPORTED THAT THEY RECEIVED THE OPEN BOOK IMAGE ON THE INSULIN PUMP SCREEN. TROUBLESHOOTING STEPS WERE PROVIDED FOR CRITICAL PUMP ERROR. THE CUSTOMER WAS ADVISED TO INSULIN PUMP WILL NEED TO BE REPLACED AND DISCONTINUE USE OF THE INSULIN PUMP AND RECOMMENDED CUSTOMER REFER TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459379 KIT MMT-1762KCN 670G V4.11 CAN MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1762KCN HG35VYD 00763000216481

    Patients

    Seq Age Sex Outcome Treatment
    1