BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 6186052 · Received December 19, 2016

    Report

    Report Number
    2032227-2016-50330
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 22, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    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 CUSTOMER HAD ISSUES WITH THEIR SENSOR. IT WAS REPORTED THAT THE CUSTOMER HAD INCONSISTENT READINGS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 88.2MG/DL. THE CUSTOMER'S SENSOR READING WAS REPORTED TO BE 50.4MG/DL. IT WAS REPORTED THAT THE SENSOR HAD MISSING CANNULA. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836306 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1