BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4241472 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50524
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 157 MG/DL AND THE SENSOR'S REPORTED BLOOD GLUCOSE LEVEL WAS 65 MG/DL. STANDARD TROUBLESHOOTING WAS PERFORMED. IT WAS DISCOVERED THAT THE SENSOR WAS 5 DAYS OLD. THE CUSTOMER HAD ALSO HAD BENT SENSORS IN THE PAST. THE CUSTOMER WAS ADVISED TO REMOVE AND REPLACE THE SENSOR. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722313 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A E144U

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR