BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4170095 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37718
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN GETTING LOW READINGS FROM THE SENSOR AND THERE HAS BEEN A 30-40 POINT DIFFERENCE. CUSTOMER STATED THAT HIS BLOOD GLUCOSE LEVEL WAS 99 MG/DL. THE CUSTOMER'S SENSOR WENT TO THRESHOLD SUSPEND AT 63 MG/DL. CUSTOMER STATED THAT THE PUMP KEPT GOING OFF AND HE WAS TRYING TO GET SOME SLEEP. IT WAS EXPLAINED THAT THERE MAY BE LARGER DIFFERENCES AFTER MEALS, BOLUS DELIVERY, OR WHEN ARROWS ARE PRESENT ON THE SENSOR GRAPH. SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS ARE NOT WITHIN AN ACCEPTABLE RANGE. INSERTION TECHNIQUES AND SITE LOCATION/SELECTION WERE REVIEWED. CUSTOMER STATED THAT THE SENSOR WAS 104 MG/DL WITH DOUBLE ARROWS. IT WAS EXPLAINED THAT THE SENSOR WAS WORKING AS IT SHOULD SINCE HE JUST FINISHED MOVING AROUND. IT WAS EXPLAINED THAT THE SENSOR WAS NOT RESPONDING AS IT SHOULD, AND HE MAY WANT TO CONSIDER REMOVING THE SENSOR. CUSTOMER WILL BE SENT A REPLACEMENT SENSOR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649492 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A E294U

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR