BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4150359 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35065
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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 DIFFERENCES BETWEEN HER SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. THE CUSTOMER STATED HER READINGS WOULD BE 100 POINTS OFF. SHE PROVIDED AN EXAMPLE WHERE HER BLOOD GLUCOSE WAS 30 MG/DL AND HER SENSOR GLUCOSE WAS 130 MG/DL. THE CUSTOMER WAS UNSATISFIED WITH HER SENSOR PERFORMANCE, AS SHE WAS UNSURE WHEN HER BLOOD GLUCOSE WAS ACTUALLY LOW. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628749 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR