BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4002623 · Received August 12, 2014

    Report

    Report Number
    2032227-2014-06920
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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 A SENSOR ERROR ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 42 MG/DL. THE CUSTOMER TREATED HERSELF FOR LOW BLOOD GLUCOSE. TROUBLESHOOTING FOUND THE SENSOR APPEARED TO BE FULLY INSERTED AND FLAT AGAINST HER SKIN. CUSTOMER ALSO STATED THE LOST SENSOR ALERT WAS OCCURING DURING THE WARM UP PERIOD. CUSTOMER STATED THE LOST SENSOR ALERT STOPPED OCCURRING 20 MINUTES AFTER ENTERING A BLOOD GLUCOSE FOR CALIBRATION. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478012 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening