BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4231804 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-36200
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 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 REPORTED HIS SENSOR READINGS ARE INACCURATE, CAUSING FALSE THRESHOLD SUSPENDS DURING THE NIGHT. THE SENSOR READING WILL BE 59 MG/DL, BUT WHEN CUSTOMER CHECK HIS BLOOD GLUCOSE IT IS 150 MG/DL. HE STATED THE NUMBERS WILL USUALLY BE OFF BY SIXTY TO ONE HUNDRED POINTS. CUSTOMER WAS ADVISED THAT PRESSURE AT THE SENSOR SITE COULD CAUSE INACCURATE SENSOR READINGS. HE WAS ADVISED OF PROPER SENSOR INSERTION AND CALIBRATION METHODS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715746 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A G284U

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR