BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 7585693 · Received June 11, 2018

    Report

    Report Number
    2032227-2018-04975
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    May 11, 2018
    Report Date
    June 11, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 WENT HOSPITAL DUE TO HIGH BLOOD GLUCOSE OF 350 MG/DL ON (B)(6) 2018. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 201MG/DL. CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF HOSPITALIZATION WAS 227 MG/DL. CUSTOMER HAD SYMPTOMS SUCH AS NOURISH. DRIVE SUPPORT CAP WAS NORMAL. THERE WAS NO LEAK AND AIR BUBBLE. CUSTOMER WAS ALLEGING FOR UNDER DELIVERING BECAUSE BLOOD GLUCOSE WAS NOT RESPONDING TO THE BOLUS WHICH HE GAVE. CUSTOMER EXPERIENCED BLOOD GLUCOSE LEVEL OF 240, 190, 287, MG/DL. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431334 RESERVOIR 3ML PUMP, INFUSION FRN MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization