BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942885 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04419
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 14, 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
    KS
    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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-03980.

    Additional Manufacturer Narrative · 1

    INSPECTED 1 OPENED AND USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFER TEST PER SPECIFICATIONS. SENSOR FAILED PER SPECIFICATION DUE TO HIGH READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED REPEATED SENSOR ERRORS. THE CUSTOMER RECEIVED A BAD SENSOR ALERT AFTER THE INITIALIZATION PERIOD WHILE GETTING READY FOR BED. AT THE TIME, THE SENSOR WAS INSERTED IN THE UPPER STOMACH. THE BAD SENSOR ALERT OCCURRED AFTER A SECOND CONSECUTIVE CALIBRATION ERROR. THE CUSTOMER BELIEVES THE ERROR RECURRENCES MAY BE DUE TO THE FACT SHE IS FINDING IT DIFFICULT TO REPLACE THE SENSORS USING HER SERTER, WHICH IS NOT READILY RELEASING THEM. THE CUSTOMER'S BLOOD GLUCOSE WAS AT 153 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418919 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A E214U

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR