BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 5124014 · Received October 2, 2015

    Report

    Report Number
    2032227-2015-52132
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 15, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF ONE OPENED AND USED ENLITE SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL COMPLAINT. THE INFORMATION HAS BEEN PROVIDED WITH THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE EXPERIENCED BLOOD GLUCOSE VERSUS SENSOR GLUCOSE DIFFERENCES WITH THRESHOLD SUSPEND WHEN BLOOD GLUCOSE WERE NOT LOW. CUSTOMER STATES SENSOR GLUCOSE WAS 62 AND BLOOD GLUCOSE WAS 163 MG/DL. THE CUSTOMER STATED THAT HE HAS NOT BEEN ABLE TO CALIBRATE TODAY BECAUSE IT IS PAST 8. THE CUSTOMER WAS ADVISED THAT SENSOR GLUCOSE VERSUS BLOOD GLUCOSE READINGS WILL BE CLOSE, BUT RARELY MATCH DUE TO HOW GLUCOSE TRAVELS IN THE BODY. THE CUSTOMER WAS ADVISED THAT THERE MAY BE LARGER DIFFERENCES AFTER MEALS, BOLUS DELIVERY OR WHEN ARROWS PRESENT ON SENSOR GRAPH.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER STATED THE THRESHOLD SUSPEND PROMPTED HIM TO SUSPEND, BUT HE HAD TO OVERRIDE IT AS HE WAS NOT AT THE LEVEL THAT IT SHOWED HIM ON. THE CURRENT BLOOD GLUCOSE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656573 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR