BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8244837 · Received January 14, 2019

    Report

    Report Number
    3004209178-2019-44478
    Event Type
    Injury
    Date Received
    January 14, 2019
    Date of Event
    December 15, 2018
    Report Date
    January 14, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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 400 MG/DL. CUSTOMER STATED THAT THEY HAD CHANGE SENSOR ALERT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN UNKNOWN, INF SET UNKNOWN, OZP MMT-7020A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37032 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other FRN UNKNOWNINF SET UNKNOWNMMT-7020A