BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 8702700 · Received June 17, 2019

    Report

    Report Number
    2032227-2019-16735
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 16, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AS WELL AS VOMITING. THE CUSTOMER STATES THEIR BLOOD GLUCOSE LEVEL WAS 582 MG/DL AT TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 572 MG/DL. CUSTOMER STATES THEY HAD 16 UNITS OF ACTIVE INSULIN. CUSTOMER REPORTS THEY FEEL OKAY TO TROUBLESHOOTING. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATES THEY WERE KEEP CHECKING THE INSULIN IF THEY NEEDS MORE, THEY ADD MORE AND DRINK WATER. CUSTOMER REPORTS THEY HAVE NOT CONTACTED THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER ALLEGES INSULIN PUMP WAS UNDER DELIVERING BECAUSE BLOOD GLUCOSE WAS GOING UP. CUSTOMER DECLINED TO TEST INSULIN PUMP. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496201 RESERVOIR 3ML PUMP, INFUSION FRN MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other FRN-UNK-RSVR, UNOMED SET