BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4780954 · Received May 19, 2015

    Report

    Report Number
    2032227-2015-16089
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 THAT HE EXPERIENCED SENSOR READING DISCREPANCIES. CUSTOMER STATED THAT THE SENSOR WAS READING 61 MG/DL BUT HIS BLOOD GLUCOSE WAS 567 MG/DL. CUSTOMER TREATED WITH A BOLUS THROUGH THE INSULIN PUMP. CUSTOMER DECLINED TO REMOVE THE SENSOR. HE STATED THAT HE WILL CONTINUE TO USE IT. SENSOR HAD BEEN INSERTED FOR 3 DAYS 22 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324894 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG0FYX3

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR