BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3954123 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04666
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 EXPERIENCED BLOOD AT THE SITE UPON INSERTION OF THE SENSOR. THE SITE WAS NOT ACTIVELY BLEEDING AT THE TIME OF THE REPORT. THE SENSOR WAS NOT TUGGED OR PULLED ON AFTER INSERTION AND WAS NOT EXPIRED. THE SENSOR WAS FULLY INSERTED. THE BLOOD GLUCOSE READING WAS 338 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430940 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG04SZ6

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR