BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3954105 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04653
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED LOST SENSOR AND TRIED TO RECONNECT TO THE SENSOR. TROUBLESHOOTING WAS PERFORMED. BLOOD GLUCOSE LEVEL WAS 175 MG/DL. CUSTOMER STATED HE DID NOT RECEIVE A NEW TRANSMITTER AND HAS CORRECT ID TRANSMITTER INPUTTED IN THE INSULIN PUMP. HE DOES NOT USE THE SOFT SENSOR. HE WAITED TWO HOURS FOR INITIALIZATION. CUSTOMER STATED HE HAD THE SENSOR INSERTED IN THE ABDOMEN, WHICH APPEARED FULLY INSERTED AND FLAT ON THE SKIN. ALARMS OCCURRED AFTER THE INITIALIZATION PERIOD AND RADIO FREQUENCY WAS NOT ESTABLISHED. CUSTOMER WAS ADVISED TO DISCONNECT THE TRANSMITTER FROM THE SENOR. CUSTOMER DID NOT NOTICE ANY DAMAGE TO THE TRANSMITTERS' CONNECTION BRIDGE. TROUBLESHOOTING WAS NOT FINISHED DUE TO CUSTOMER HAD TO GO, ADVISED TO CHANGE OUT SENSOR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430934 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG01PVS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR