BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4183532 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40320
    Event Type
    Injury
    Date Received
    October 18, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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 332 MG/DL. THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO CHEST PAINS AND SHORTNESS OF BREATH. THE CUSTOMER ALSO HAD BLOOD CLOTS AT THE TIME OF HOSPITALIZATION. IT WAS ALSO REPORTED THAT THE CUSTOMER WAS BLEEDING AT THE SITE OF THE SENSOR INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663867 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization