BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR

    MDR report key: 7640164 · Received June 26, 2018

    Report

    Report Number
    2032227-2018-07465
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    May 25, 2018
    Report Date
    June 26, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF ALMOST 400 MG/DL. THE CUSTOMER ALSO HAD BLOOD GLUCOSE LEVEL OF 120 , 180, 240, 285 AND 340 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479054 RESERVOIR RESERVOIR, INSULIN PUMP FRN MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other