BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 7728037 · Received July 27, 2018

    Report

    Report Number
    3004209178-2018-96553
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    May 22, 2018
    Report Date
    July 27, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 AT 3 AM WITH BLOOD GLUCOSE OF 34 MG/DL. THE CUSTOMER'S ANOTHER BLOOD GLUCOSE LEVEL WAS IN LOW 90, 180, 157, 44 MG/DL. THE CUSTOMER WAS TREATED WITH SYRUP THROUGH INTRAVENOUS, LIKE A SHOT OF SYRUP. THE PATIENT TROUBLESHOOTING WAS NOT DONE FOR LOW BLOOD GLUCOSE AND OVER DELIVERY. THE CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BG EVENT. THE CUSTOMER REPORTED THAT AUTO MODE WAS AUTOMATICALLY DELIVERED INSULIN AT THE TIME OF THE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570492 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2FWL0 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O