BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 7623291 · Received June 20, 2018

    Report

    Report Number
    2032227-2018-06713
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    May 21, 2018
    Report Date
    June 20, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 422,387, 202, 454, 369, 400 MG/DL. CUSTOMER TREATED WITH INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED HIGH BLOOD GLUCOSE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464939 RESERVOIR 3ML PUMP, INFUSION FRN MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other