BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3894861 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03357
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    CUSTOMER CALLED TO REPORT A SKIN INFECTION AT HER SENSOR INSERTION SITE. CUSTOMER WENT TO VISIT HER FAMILY DOCTOR AND WAS GIVEN ANTIBIOTICS. THE CUSTOMER HAD BEEN OFF THE INSULIN PUMP FOR 2 DAYS PRIOR TO VISITING THE DOCTOR. CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF THE CALL TO HER DOCTOR. CURRENT BLOOD GLUCOSE READING IS 129 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369922 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B194U

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention