BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3981721 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06050
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THREE OPENED AND USED SENSORS WERE INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. ONE OF THE THREE SENSOR FAILED WITH HIGH READINGS AND THE OTHER TWO PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SENSOR READINGS ARE OFF AND THEY ARE ONLY LASTING TWO DAYS. CUSTOMER REPORTED THE INSULIN PUMP HAS ALARMED CALIBRATION ERROR AND CHANGE SENSOR. CUSTOMER DECLINED TO TROUBLESHOOT, JUST WANTED TO REPLACE THE SENOR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 222 MG/DL. CUSTOMER WAS ADVISED TO MONITOR NEW SENSOR AND UPLOAD DATA TO CARELINK. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457068 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A D054U

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR