BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8685640 · Received June 10, 2019

    Report

    Report Number
    2032227-2019-14051
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    November 1, 2018
    Report Date
    June 10, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    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 LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 50 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 117 MG/DL. CUSTOMER ALSO STATED THAT THE SITE WAS ACTIVELY BLEEDING. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR LOW BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH GLUCOSE TABLET. INSULIN PUMP WILL NOT BE RETURNED DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478678 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2F1QA 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other UNOMED INF SET, FRN-RSVR, OZP-MMT-7020