BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 8459104 · Received March 28, 2019

    Report

    Report Number
    3004209178-2019-73350
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    March 20, 2019
    Report Date
    March 28, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000187422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 CUSTOMER EXPERIENCED HYPERGLYCEMIA AND INSULIN PUMP HAD INSULIN FLOW BLOCKED ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 20 MMOL/L, 23 MMOL/L, 22 MMOL/L AT TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 19.9 MMOL/L. THE CUSTOMER ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH SYRINGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253233 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG33J4X 00763000187422

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FRN-UNK-RSVR, UNO INF SET