BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8538660 · Received April 23, 2019

    Report

    Report Number
    3004209178-2019-85909
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 10, 2019
    Report Date
    April 22, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. INITIALLY THE BLOOD GLUCOSE VALUE WAS 100 MG/DL. THEN CUSTOMER USED AUTO MODE AND BLOOD GLUCOSE ROSE AT 145 AND 400 MG /DL. THEN BLOOD GLUCOSE RUN AROUND 200, 262, 274 MG/DL. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH READINGS. CUSTOMER WAS ADVISED TO CHANGE THE INFUSION SET, RESERVOIR AND INSULIN AND TO TREAT PER HEALTHCARE PROFESSIONAL'S RECOMMENDATION. THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331739 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3545P 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other FRN-RSVR, UNOMED INF SET