BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 5170508 · Received October 23, 2015

    Report

    Report Number
    2032227-2015-59132
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEIR SENSOR DISPLAYING WRONG READINGS OF SENSOR AND BLOOD GLUCOSE. THE PATIENT'S BLOOD GLUCOSE WAS 120 MG/DL AT THE TIME OF THE INCIDENT BUT THEIR SENSOR GLUCOSE READINGS WERE FALSELY DISPLAYING 40 MG/DL. THE CUSTOMER HAD ALSO RECEIVED A LOW THRESHOLD SUSPEND DUE TO THE ISSUE. THE CUSTOMER WAS ASSISTED WITH TROUBLE SHOOTING AND WAS INFORMED THAT THE SENSOR NEEDS TO BE REPLACED. THE CUSTOMER WAS EDUCATED ON THE PROPER SITE AND INSERTION TECHNIQUE OF THE SENSOR TO AVOID ANY ISSUES IN THE FUTURE. THE CUSTOMER WAS SENT A NEW SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701324 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR