BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942790 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04287
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 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. 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

    ONE OPENED AND USED SENSOR WAS INSPECTED AND THE ELECTRODE WAS FOUND BENT. THE SENSOR FAILED PER INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED ABOUT HAVING MULTIPLE SENSOR ERRORS. CUSTOMER STATED THAT HE HAD LOW BLOOD GLUCOSE OF 60 MG/DL IN THE MORNING AND TREATED WITH FOOD INGESTION; THEN HIS GLUCOSE WENT UP TO 273 MG/DL AND RECEIVED A HIGH PREDICT ALERT AND TREATED WITH INSULIN PUMP. CUSTOMER STATED HE INSERTED SENSOR IN THE MORNING; TWO INCHES AWAY FROM THE INFUSION SET. DURING TROUBLESHOOT; THE ALERT HISTORY WAS CHECKED AND HISTORY SHOWED THE CUSTOMER RECEIVED CALIBRATION ERROR, SENSOR ERROR, LOST SENSOR AND SENSOR END ALERTS. CUSTOMER STATED THE SENSOR END ALERT OCCURRED AFTER INITIALIZATION. CUSTOMER REMOVED THE SENSOR AND NOTICED THE SENSOR CANNULA WAS COMPLETELY BENT AGAINST THE ADHESIVE. CURRENT BLOOD GLUCOSE LEVEL 93 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419138 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B114U

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR