BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3893877 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03265
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    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. PLEASE SEE ALSO MFR REPORT NUMBER 3004209178-2014-85877.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. CALLER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE READING WAS 65 MG/DL AT THE TIME OF ADMISSION. CALLER STATED THAT THE CUSTOMER IS VERY BRITTLE, HIS DOCTOR MADE CHANGES TO HIS INSULIN PUMP SETTINGS AND THE SENSOR CANNOT KEEP UP, THE READINGS FLUCTUATE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371752 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization