BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-7020A ENLITE3 5PK US

    MDR report key: 7595416 · Received June 13, 2018

    Report

    Report Number
    2032227-2018-05393
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 10, 2018
    Report Date
    June 13, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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 WAS 430MG/DL. CUSTOMER EXPERIENCED DIFFERENT BLOOD GLUCOSE LEVELS WAS 120, 140, 400, 230, 324, 430MG/DL. CUSTOMER DECLINED FOR TROUBLESHOOTING. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438126 SENSOR MMT-7020A ENLITE3 5PK US ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7020A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other MMT-1780KPK| MMT-975