BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4132455 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31073
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 BY THE CUSTOMER THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVELS OF 418 MG/DL. CUSTOMER STATED THEIR SENSOR CALIBRATION ISSUES AND INTAKE OF LARGE AMOUNTS OF FOOD CAUSED THE ELEVATED BLOOD GLUCOSE LEVELS. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 172 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611891 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR