BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4213336 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37543
    Event Type
    Injury
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 REPORTS TO BLOOD GLUCOSE VERSUS SENSOR GLUCOSE DIFFERENCES. CUSTOMER STATES BLOOD GLUCOSE IS 600 MG/DL AND SENSOR GLUCOSE WAS 143. CUSTOMER ALSO STATES THERE IS CONDENSATION UNDER DISPLAY SCREEN. CUSTOMER'S BLOOD GLUCOSE OF 600 MG/DL WAS TREATED WITH INSULIN PUMP. CUSTOMER WAS EXPLAINED THE REASONS FOR SENSOR GLUCOSE VERSUS BLOOD GLUCOSE. CUSTOMER WAS ADVISED THAT SENSORS WILL BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648974 SENSOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR