BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4211839 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44856
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 A SENSOR PROBLEM OF THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER STATED THAT THEIR WAS TOO MUCH ALARM AND THEIR WAS ISSUES BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE. THE CUSTOMER WAS THINKING OF PUTTING NEW SENSOR. THE CUSTOMER WAS ADVISED TO CALL IF SHE NEED HELP WITH SENSOR INSERTION. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692473 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening