BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3930692 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03754
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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 LOST SENSOR ALERTS. HE ALSO STATED THAT HE HAS HAD TO USE PLIERS TO PULL THE SENSOR OUT OF THE SERTER. CUSTOMER VERIFIED THAT THE CORRECT TRANSMITTER ID IS PROGRAMMED IN THE INSULIN PUMP. HE ALSO STATED THAT HE NOW HAS TO CHARGE THE TRANSMITTER MORE FREQUENTLY THAN HE USED TO. HE STATED THAT THE INSULIN PUMP IS NOT COMMUNICATING WITH THE TRANSMITTER. A TEST PLUG PROCEDURE WAS DONE AND SHOWED THAT THE TRANSMITTER WAS FUNCTIONAL. THE BLOOD GLUCOSE READING WAS 145 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408869 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A C284U

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR