BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 6000118 · Received October 5, 2016

    Report

    Report Number
    2032227-2016-27728
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 10, 2016
    Report Date
    September 10, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 THEIR INSULIN PUMP INAPPROPRIATELY SUSPENDED DUE TO A SENSOR GLUCOSE OF 46 MG/DL DESPITE A BLOOD GLUCOSE OF 191 MG/DL. TROUBLESHOOTING WAS INITIATED FOR THE DISCREPANCY IN SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS AND THE CAUSES OF THE DISCREPANCY WERE REVIEWED WITH THE CUSTOMER. THE SENSOR WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651214 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR