BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3924297 · Received July 9, 2014

    Report

    Report Number
    2032227-2014-03515
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 REPORTED HOSPITALIZATION DUE TO DIABETES. CUSTOMER WAS VOMITING, DIZZY AND UNABLE TO EAT. CUSTOMER DOES NOT REMEMBER THE BLOOD GLUCOSE AT THE TIME OF THE EVENT. DIAGNOSED BENIGN POSITIONAL VERTIGO. DUE TO VERTIGO CUSTOMER HAD TO REDUCE THE BASAL RATES. CUSTOMER WAS NOT HOSPITALIZED DUE TO LOW OR HIGH BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400190 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization