BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 8766507 · Received July 8, 2019

    Report

    Report Number
    2032227-2019-26360
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 15, 2019
    Report Date
    July 8, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INSULIN PUMP OVER DELIVERY ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 58 MG/DL AT TIME OF INCIDENT. THE CUSTOMER WAS TREATED WITH MOUNTAIN DEW DRINK. THE CUSTOMER ALLEGES PUMP WAS OVER DELIVERING BECAUSE BLOOD GLUCOSE WAS GOING DOWN EVEN AFTER DRINKING 6 CANS OF MOUNTAIN DEW WITHIN 30 MINUTES AND BLOOD GLUCOSE WAS STILL GOING DOWN. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562415 RESERVOIR 3ML PUMP, INFUSION FRN MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR