BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4183527 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40317
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 174 MG/DL. THE CUSTOMER REPORTED HAVING ISSUES WITH THE SENSOR GLUCOSE LEVELS READING BEING DIFFERENT FROM THE BLOOD GLUCOSE LEVELS READING. THE CUSTOMER ALSO REPORTED THAT THE THRESHOLD SUSPEND FEATURE OF THE INSULIN PUMP ACTIVATED EVEN THOUGH IT WAS NOT SUPPOSED TO. THE CUSTOMER REPORTED THAT THE INSULIN PUMP ACTIVATED THE THRESHOLD SUSPEND WITH A SENSOR GLUCOSE READING OF 60 MG/DL WHERE THE ACTUAL BLOOD GLUCOSE LEVEL WAS 128 MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663948 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR