BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3974174 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05224
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 A DIFFERENCE BETWEEN HIS SENSOR GLUCOSE AND BLOOD GLUCOSE READING. THE SENSOR GLUCOSE READING WAS 88 MG/DL AND BLOOD GLUCOSE READING WAS 163 MG/DL. CUSTOMER WAS NOT ABLE TO UPLOAD THE READINGS. THE CUSTOMER CALIBRATED HIS SENSOR AND REPORTED HIS SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS ARE TRENDING UP. HE STATES THAT HE RARELY HAS THIS PROBLEM. CUSTOMER HAS BEEN ADVISED THAT SENSOR MAY HAVE GOTTEN COMPRESSED OVERNIGHT. THE CUSTOMER ALSO STATED THAT HE BOLUSED OFF THE SENSOR OVERNIGHT. CUSTOMER HAS BEEN ADVISED NEVER TO BOLUS OR TREAT OFF THE SENSOR READING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450132 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR