BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4813629 · Received June 2, 2015

    Report

    Report Number
    2032227-2015-17711
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE RECEIVED FOUR SENSOR ERROR ALERTS. DURING THE CALL, THE CUSTOMER STATED HIS BLOOD GLUCOSE WAS 568 MG/DL. HE STATED THAT THE HIGH BLOOD GLUCOSE WAS DUE TO PERSONAL PROBLEMS AND HE TREATED WITH A MANUAL INJECTION. THE CUSTOMER COULD NOT TROUBLESHOOT BECAUSE HE WAS DRIVING. THE CUSTOMER WAS ADVISED TO SELECT RECONNECT OLD SENSOR AND CALIBRATE WHEN STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356967 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR