BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 6128933 · Received November 28, 2016

    Report

    Report Number
    2032227-2016-46071
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    October 18, 2016
    Report Date
    November 1, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE EXPERIENCED SENSOR GLUCOSE VERSUS BLOOD GLUCOSE DIFFERENCES WITH THRESHOLD SUSPEND. CUSTOMER'S SENSOR GLUCOSE WAS 60 AND BLOOD GLUCOSE WAS 115 MG/DL. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER WAS ADVISED ON PROPER SENSOR USAGE AND CALIBRATION TECHNIQUES. CUSTOMER WAS ADVISED THAT SENSOR WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781352 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR