BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4103468 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26361
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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

    DURING A FOLLOW UP CALL THE CUSTOMER STATED THAT THERE WERE DISCREPANCIES BETWEEN THE SENSOR GLUCOSE VALUES AND THE BLOOD GLUCOSE VALUES. THE SENSOR GLUCOSE WAS 63 MG/DL BUT THE BLOOD GLUCOSE WAS 110 MG/DL. ANOTHER READING WAS PROVIDED WHERE THE SENSOR GLUCOSE WAS OVER 400 MG/DL BUT THE BLOOD GLUCOSE WAS 289 MG/DL. THE CUSTOMER STATED THAT THE SENSORS WERE LASTING ONLY A DAY AND A HALF. UPON REMOVAL OF THE SENSOR FROM THEIR BODY THEY NOTICED THAT THE CANNULA WAS SEVERELY BENT. THE CUSTOMER STATED THAT THEY CALIBRATED THE DEVICE TWICE, OR EVERY SIX TO EIGHT HOURS, WHEN THEY WERE PROMPTED TO DO SO. THE INSULIN PUMP HAD ALARMED CALIBRATION ERRORS AND CHANGE SENSOR ALERTS. THEY CHANGED THE SENSOR AND THE INSULIN PUMP HAD STARTED GETTING BIZARRE READINGS THREE TO FOUR DAYS LATER. THE CUSTOMER HAD CHANGED THE INFUSION SET AT THAT TIME AND THE READINGS HAD BECOME BETTER. AT THE TIME OF THE PHONE CALL THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584820 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A F044U

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR