BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE MMT-7008B

    MDR report key: 8686100 · Received June 11, 2019

    Report

    Report Number
    2032227-2019-14384
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    June 4, 2019
    Report Date
    June 11, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    UDI-DI
    00643169541719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. THE CUSTOMER¿S BLOOD GLUCOSE WAS 140 MG/DL AND THE SENSOR GLUCOSE WAS 70 MG/DL. CUSTOMER'S OTHER BLOOD GLUCOSE VALUE 159 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. SENSOR VALUE THAT TRIGGERED THE SUSPEND EVENT WAS 70 MG/DL. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS 70 MG/DL. 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
    482579 SENSOR ENLITE MMT-7008B ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC MINIMED MMT-7008B B289P 00643169541719

    Patients

    Seq Age Sex Outcome Treatment
    1