BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4143396 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30194
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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 THAT SHE HAD INACCURATE SENSOR READINGS WHEN SHE FIRST STARTED USING THE SENSORS. THE INACCURATE SENSOR READINGS WOULD LEAD TO CALIBRATION ERRORS. SHE STATED HER BLOOD GLUCOSE WOULD BE 462, BUT HER SENSOR WOULD BE READING LOW. THIS LAST OCCURRED ABOUT THREE WEEKS AGO. SOMETIMES THE SENSORS DO NOT STICK VERY WELL AND CAUSE SLIGHT IRRITATION. THIS LAST OCCURRED ABOUT A MONTH AGO. CUSTOMER DECLINED TROUBLESHOOTING, BECAUSE SHE HAS NOT HAD ANY ISSUES WITH HER SENSORS RECENTLY. SHE THINKS THE PROBLEMS WERE CAUSED BY USER ERROR SINCE SHE WAS NEW TO THE SENSORS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603315 SENSOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention