BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4251876 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52774
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS RECEIVING LOST SENSOR ALARMS. CUSTOMER ALSO REPORTED RECEIVING A WEAK SIGNAL ALARM FIRST. CUSTOMER WAS ADVISED THEIR SENSOR MAY NOT BE WORKING OR DAMAGED. THE CUSTOMER ALSO REPORTED HAVING A HIGH BLOOD GLUCOSE OF 411 MG/DL. CUSTOMER HAS TREATED THEIR BLOOD GLUCOSE WITH THE INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737700 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG07BMW

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR