BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942884 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04417
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 RECEIVED A LOST SENSOR ALARM AFTER THE INITIALIZATION PERIOD. THE CUSTOMER'S BLOOD GLUCOSE WAS 214 MG/DL. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THE SENSOR DID NOT APPEAR TO BE FULLY INSERTED AND FLAT AGAINST THE SKIN; THE CUSTOMER STATES THIS LOOSENESS WAS DUE TO AN ISSUE WITH THE ADHESIVE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419437 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A D294U

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR