BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8203003 · Received December 28, 2018

    Report

    Report Number
    2032227-2018-80182
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    December 4, 2018
    Report Date
    December 28, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 43 MG/DL. THE BLOOD GLUCOSE WAS 159, 51, 132, 159 AND 156 MG/DL AND SENSOR GLUCOSE WAS 65, 66 AND 62 MG/DL. THE CUSTOMER WAS TREATED FOR LOW BLOOD GLUCOSE. THE INSULIN DELIVERY WAS NOT SUSPENDED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. OZP-MMT-7020-SNSR, FRN-MMT-332-RSVR, UNOMED INF SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043829 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2SXA0 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other MMT-7020, FRN-MMT-332, UNOMED INF SET