BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4862352 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19863
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 VIA PHONE, HE EXPERIENCED HIGH BLOOD GLUCOSE OF 400 MG/DL BECAUSE HE MADE AND ATE COOKIES. CUSTOMER DECLINED BEING TRANSFERRED TO PERFORM TROUBLESHOOTING. CUSTOMER IS NOT RETURNING THE DEVICE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405712 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other