BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8662450 · Received June 3, 2019

    Report

    Report Number
    2032227-2019-10695
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 24, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 THE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 239 MG/DL AT THE TIME OF INCIDENT AND WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS DOWN TO HER LAST INFUSION SET AND THE BLOOD GLUCOSE WAS HIGH EARLIER SO THEY SUSPECTED THAT THE CANNULA WAS BENT AND MAY PROMPT THE CUSTOMER TO CHANGE INFUSION SET. THE CUSTOMER REPORTED THAT THE INSULIN EXITED AT THE QUICK RELEASE. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455708 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2Z9FS 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR