BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3974638 · Received August 3, 2014

    Report

    Report Number
    2032227-2014-05242
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 IS EXPERIENCING DIFFERENCES BETWEEN HIS SENSOR GLUCOSE AND BLOOD GLUCOSE, SENSOR ERROR, CALIBRATION ERROR; LOW PREDICT ALERT AND SOME IRRITATION ON THE SITE. CUSTOMER REPORTS LOW BLOOD GLUCOSE OF 47MG/DL. CUSTOMER STATES HE HAS PUMP LOW SET AT 80MG/DL, BUT DOES NOT USE CONTINUES GLUCOSE MONITORING SYSTEM BECAUSE OF THE ALARMS. CUSTOMER WAS ENCOURAGED TO GO BACK ON CONTINUES GLUCOSE MONITORING SYSTEM. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 137 MG/DL. CUSTOMER WAS ADVISED TO CALIBRATE ONLY WHEN STABLE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452393 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A C244U

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR