BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 5981036 · Received September 27, 2016

    Report

    Report Number
    2032227-2016-19879
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 6, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 CUSTOMER EXPERIENCED SENSOR GLUCOSE VERSUS BLOOD GLUCOSE DIFFERENCES WITH THRESHOLD SUSPEND. CUSTOMER'S SENSOR GLUCOSE WAS 2.2 AND BLOOD GLUCOSE WAS 6.7 MMOL/L. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER WAS ADVISED ON PROPER SENSOR USAGE. CUSTOMER WAS ADVISED TO MONITOR BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632078 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A F086P

    Patients

    Seq Age Sex Outcome Treatment
    1