BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942712 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-03991
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 ALERTS CALIBRATION ERROR. THE CUSTOMER'S MOTHER STATED THAT THE SENSOR WILL SAY CHANGE SENSOR OR LOST SENSOR. THE BLOOD GLUCOSE READING IS 386 MG/DL. CUSTOMER HAS TREATED WITH THE INSULIN PUMP. ADVISED CALLER THAT THE ENLITE SENSOR IS NOT APPROVED FOR SOMEONE UNDER THE AGE OF 16. CUSTOMER IS TEN YEARS OLD. THIS IS OFF LABEL USE. WHICH IS NOT PROMOTED BY MEDTRONIC. ADVISED CALLER TO TALK WITH PHYSICIAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418209 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A C134U

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR