BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4211949 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-45370
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    IT WAS REPORTED THAT THE DIFFERENCE BETWEEN THE CUSTOMER'S ACTUAL BLOOD GLUCOSE READINGS AND THE SENSOR'S READINGS WAS SIGNIFICANT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 338 MG/DL AND THE CUSTOMER'S SENSOR SHOWED A READING OF 44 MG/DL. STANDARD TROUBLESHOOTING AS PERFORMD. THE SENSOR HAD BEEN IN USE FOR ALMOST 5 DAYS. THE CUSTOMER WAS ADVISED TO CHANGE HER SENSOR. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692970 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG06S78

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR