BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3952649 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04004
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE INSULIN PUMP WAS ALARMING LOST SENSOR. CUSTOMER'S BLOOD GLUCOSE WAS 442 MG/DL. TROUBLESHOOTING WAS PERFORMED FOR LOST SENSOR. TRANSMITTER ID IS CORRECT IN THE INSULIN PUMP. CUSTOMERS' TECHNIQUE OF TAPING WAS REVIEWED. CUSTOMER DOES NOT HAVE THE TEST PLUG, UNABLE TO TEST. THE SENSOR WAS NOT BENT. CUSTOMER REPORTED ANOTHER SENSOR THAT WAS CAUSING THE INSULIN PUMP TO ALARM LOST SENSOR. CUSTOMER STATED THE BOX OF SENSOR ONLY LAST TWO AND HALF DAYS. CUSTOMER STATES SHE FEELS LIKE SENSOR IS PINCHING IT IS BENT AGAIN. TROUBLESHOOTING WAS PERFORMED AGAIN. BLOOD GLUCOSE WAS 200MG/DL. INITIATED PERIOD WAS COMPLETED WHEN ALARM OCCURRED. CUSTOMER DECLINED TO PULL THE SENSOR WANTED TO WAIT FOR THE TWO HOUR WARMING PERIOD. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431423 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG041G7

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR