BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4173590 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38277
    Event Type
    Injury
    Date Received
    October 15, 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
    MD
    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 WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVELS. BLOOD GLUCOSE LEVELS AT THE TIME OF THE HOSPITALIZATION 800MG/DL. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. CUSTOMER ALSO REPORTED THAT THEY HAVE BEEN IN AND OUT OF THE HOSPITAL DUE TO GASTROPARESIS AND SYNCOPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654766 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization