BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3954116 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04676
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 18, 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
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 2 OPENED AND USED ENLITE SENSORS SHOWED THAT THEY FUNCTIONED PROPERLY AND PASSED ALL FUNCTIONAL TESTING. HOWEVER, THE ENLITE SENSORS WERE RECEIVED WITH BENT CANNULA, UNABLE TO CONFIRM IF THE CUSTOMER RECEIVED THE SENSORS IN SAID CONDITION DUE TO THE CUSTOMER RETURNED THE SENSORS OPENED AND USED.

    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

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED REPEATED SENSOR ERROR ALERTS. THE CUSTOMER'S BLOOD GLUCOSE WAS 245 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THE ALERT OCCURRED AFTER INITIALIZATION, AND THE SENSOR WAS FULLY INSERTED AND FLAT AGAINST THE SKIN. NO DAMAGE TO CONNECTION BRIDGE OR PINS WAS FOUND. A TEST PLUG PROCEDURE WAS PERFORMED AND PASSED. THE CUSTOMER STATED THE SENSOR WAS NOT FULLY BENT BUT HAD A CURVE TO IT. IT WAS DETERMINED THE PATIENT WAS USING A SINGLE METER FOR CALIBRATIONS AND HE WAS NOT CALIBRATING AT THE APPROPRIATE TIMES OR WITH APPROPRIATE FREQUENCY. THE CUSTOMER WAS NOT ADHERING TO CALIBRATION RECOMMENDATIONS PER INSTRUCTIONS FOR USE. HE WAS ADVISED OF CORRECT CALIBRATION PROTOCOL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430575 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A C244U

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR