BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE MMT-7008B

    MDR report key: 8622860 · Received May 20, 2019

    Report

    Report Number
    2032227-2019-04263
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    May 13, 2019
    Report Date
    May 19, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    UDI-DI
    00643169541719
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    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

    IT WAS REPORTED THAT THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM AND THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 25 MMOL/L AND THE SENSOR GLUCOSE WAS 3.4 MMOL/L. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 3.4 MMOL/L. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 3.4 MMOL/L. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE AND BLOOD GLUCOSE DIFFERENCE. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416647 SENSOR ENLITE MMT-7008B ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC MINIMED MMT-7008B B149P 00643169541719

    Patients

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