BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3981920 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-05657
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 CUSTOMER IS HAVING DIFFERENCES IN SENSOR BLOOD GLUCOSE 6MMOL/L AND BLOOD GLUCOSE 9MMOL/L. CUSTOMER HAS BEEN WEARING SENSOR FOR TWO DAYS. CUSTOMER CALIBRATES FOUR TIMES PER DAY. THE BLOOD GLUCOSE READING WAS UNKNOWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457951 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008B

    Patients

    Seq Age Sex Outcome Treatment
    1