BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3974318 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05337
    Event Type
    Malfunction
    Date Received
    August 1, 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
    AU
    Reporter Occupation
    OTHER

    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 THAT THE SENSOR GLUCOSE READING AND THE BLOOD GLUCOSE READING HAD HUGE DIFFERENCES. THE BLOOD GLUCOSE READING WAS 44 MG/DL COMPARED WITH THE SENSOR GLUCOSE READING OF 264 MG/DL. THE CUSTOMER FOLLOWED PROPER CALIBRATION PROTOCOL AND HAD BEEN WEARING THE SENSOR FOR 2 DAYS; HOWEVER, IT WAS INSERTED IN THE LEG. THE CUSTOMER DELIVERED BOLUS WITHOUT CHECKING WITH A BLOOD GLUCOSE METER. IT WAS ALSO NOTED THAT THE INSULIN PUMP ALARMED WEAK SIGNAL VERY OFTEN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450217 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008B

    Patients

    Seq Age Sex Outcome Treatment
    1