BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942882 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04410
    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 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.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED THE INSULIN PUMP IS ALARMING SENSOR ERROR. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 109 MG/DL, WAS LOW BEFORE THE CALL. THE SENSOR WAS INSERTED IN THE ABDOMEN; IT APPEARS TO BE FULLY INSERTED AND FLAT AGAINST THE SKIN. CONNECTERS DO NOT SEEM DAMAGED. TRANSMITTER WAS TEST, DETERMINED FUNCTIONING CORRECTLY. AFTER TEST CUSTOMER WAS ADVISED TO; RECONNECTED TRANSMITTER AND SENSOR AND "START NEW SENSOR" TO RECONNECT THE SENSOR TO THE INSULIN PUMP. CUSTOMER'S WIFE ALSO REPORTED THE NEEDLE CAME OFF IN TWO SENSORS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418909 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A C174U

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR