BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3982087 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06137
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ONE OPENED AND USED SENSOR WAS INSPECTED AND THE NEEDLE WAS FOUND BENT INSIDE OF THE SENSOR BASE. IT COULD NOT BE CONFIRMED THAT THE CUSTOMER RECEIVED THE SENSOR IN THIS CONDITION AS IT WAS RETURNED OPENED AND USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER'S BLOOD GLUCOSE WAS 437 MG/DL, TREATED WITH SEVEN UNITS OF INSULIN. CUSTOMER ALSO REPORTED ISSUES WITH THE SENSOR READINGS. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED THE SENSOR GLUCOSE WAS 87 MG/DL AND BLOOD GLUCOSE LEVEL WAS 437 MG/DL, 80.1 PERCENT DIFFERENCE. CUSTOMER SENSOR GLUCOSE GRAPH DETERMINES THEY ARE TRENDING OPPOSITE DIRECTIONS. NO RAPID CHANGE ARROWS NOTED ON THE DEVICE. AVERAGE DIFFERENCE WAS CALCULATED AT 82.2 PERCENT. CUSTOMER WAS ADVISED THE SENSOR APPEARED TO BE REACTING TO CHANGE IN GLUCOSE. CUSTOMER STATED HE HAS BEEN HAVING OFF READINGS ON THE SENSOR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456576 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention