BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945217 · Received July 18, 2014

    Report

    Report Number
    2032227-2014-04602
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 PATIENT WAS NOT HAPPY WITH THE SENSORS BECAUSE SHE KEEPS GETTING ALARMS, AND THEY BOTHER HER. THE TYPES OF ALARMS WERE NOT MENTIONED, AND TROUBLESHOOTING WAS DECLINED AS THE PATIENT NO LONGER WANTED TO WEAR THE PRODUCT. EMAILED THE PATIENT'S COMPANY REPRESENTATIVE AND TERRITORY MANAGER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422228 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR