BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4141868 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33620
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 4, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 2 OPENED AND USED ENLITE SENSORS. 1 OF 2 FAILED SENSORS DUE TO LOW READINGS 2ND FAILED SENSOR DUE TO HIGH READINGS. ALSO FOUND 2 CANNULA BENT UNABLE TO CONFIRM CUSTOMER RECEIVED SENSOR IN SAID CONDITION DUE TO CUSTOMER RETURNED OPENED AND USED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR DEVICE WAS CALIBRATING INCORRECTLY. ASSISTED CUSTOMER WITH PROGRAMMING DEVICE AND TROUBLESHOOTING. CUSTOMER STATES THAT THE SENSOR WOULD INFORM THEM THEY WERE EITHER HIGH OR LOW, WHEN THEY WERE ACTUALLY STABLE. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE HAD BEEN DROPPED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 110 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621724 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A E164U

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR