BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3854935 · Received June 9, 2014

    Report

    Report Number
    2032227-2014-02934
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    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

    THE CUSTOMER'S FATHER REPORTED THAT THE PATIENT'S SENSOR ELECTRODE BROKE. THE PATIENT BELIEVES THAT THE CANNULA MAY STILL BE IN THE SKIN BUT IS UNSURE. THE PATIENT'S BLOOD GLUCOSE READING IS 198 MG/DL AND WAS ADVISED TO SEE HIS DOCTOR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336087 SENSOR ENLITE CGM MDS MEDTRONIC MINIMED MMT-7008A C124U

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR