BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3974119 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05261
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 25, 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
    WI
    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 HE STOPPED USING THE SENSOR, DUE TO SENSOR READING BEING OFF. CUSTOMER STATED HE WILL CHECK HIS BLOOD GLUCOSE LEVEL AND IT WILL BE DIFFERENT FROM HIS SENSOR GLUCOSE READINGS. CUSTOMER STATE THE INSULIN PUMP ALSO ALARMED CALIBRATION ERROR. CUSTOMER WOULD INPUT HIS BLOOD GLUCOSE READING AND A FEW MINUTES LATER IT WILL PROMPT HIM TO INTER BLOOD GLUCOSE AGAIN. CUSTOMER WAS ADVISED TO REACH HELPLINE WHEN ISSUES OCCUR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450677 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR