BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8502714 · Received April 11, 2019

    Report

    Report Number
    3004209178-2019-79872
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    March 29, 2019
    Report Date
    April 11, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 459 MG/DL. CUSTOMER¿S CURRENT BLOOD LEVEL WAS 311 MG/DL. CUSTOMER HAD SYMPTOM SUCH AS NAUSEA. CUSTOMER EXPERIENCED BLOOD GLUCOSE LEVEL OF 237, 198, 261, 125, 218, 189, 222, 422, 417, 508, 445, 350, 308, 344, 370, 155, 433, 342, 214, 201, 311, 330 MG/DL. CUSTOMER WAS ALLEGING INSULIN PUMP FOR UNDER DELIVERING. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296805 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG35C29 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other FRN UNKNOWN, INF SET UNKNOWN