BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 9340373 · Received November 19, 2019

    Report

    Report Number
    2032227-2019-119570
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    November 11, 2019
    Report Date
    November 19, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000166526
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS OF 24, 36, AND 46 MG/DL. CUSTOMER HAD BLOOD GLUCOSE LEVEL OF 243, 298, 296, 285, 111, AND 162 MG/DL. CUSTOMER WAS TREATED WITH GLUCAGON. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR AUTO MODE. CUSTOMER STATED THAT THE SENSOR WAS UPDATING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135084 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG3KQQ1 00763000166526

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other FRN-MMT-332A,UNOMED MMT-377,MMT-7020-OZP