BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4210091 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44578
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. SEE MEDWATCH 2032227-2014-44579 AND 203222-2014-44580.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER HAS ISSUES REGARDING THEIR SENSOR DISPLAYING WRONG READINGS OF SENSOR AND BLOOD GLUCOSE. THE PATIENT'S BLOOD GLUCOSE WAS AT 126 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS ASSISTED WITH TROUBLE SHOOTING AND WAS INFORMED THAT THE SENSOR THE INSULIN PUMP AS WELL AS THE SENSOR WORKS AS DESIGNED. THE CUSTOMER WAS ADVISED TO DOWNLOAD CARELINK.. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693968 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR