BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 8662350 · Received June 3, 2019

    Report

    Report Number
    2032227-2019-10667
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 19, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 479 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER STATES THE INSULIN EXITED. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD UNDER DELIVERY. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457181 RESERVOIR 3ML PUMP, INFUSION FRN MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other UNOMED INF SET