BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4211837 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44853
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A SENSOR PROBLEM ON INSULIN PUMP. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS READING THRESHOLD SUSPEND. THE TROUBLESHOOTING WAS PERFORMED. IT WAS EXPLAINED TO CUSTOMER THAT THE SENSOR GLUCOSE AND BLOOD GLUCOSE METER READINGS WILL BE CLOSE, BUT RARELY MATCH DUE TO HOW GLUCOSE TRAVEL INTO THE BODY. THE CUSTOMER IS STILL WEARING THE SENSOR. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691631 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A G254U

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR