BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4243961 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-51156
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 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

    RELIABILITY ANALYSIS INSPECTED ONE OPENED/USED ENLITE SENSOR AND PERFORMED TESTING. THE SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF ABOUT 178 MG/DL. THE CUSTOMER REPORTED HAVING ISSUES WITH THE SENSOR GLUCOSE LEVELS READING BEING DIFFERENT FROM THE BLOOD GLUCOSE LEVELS READING. THE CUSTOMER ALSO REPORTED THAT THE THRESHOLD SUSPEND FEATURE OF THE INSULIN PUMP ACTIVATED EVEN THOUGH IT WAS NOT SUPPOSED TO. THE THRESHOLD SUSPEND FOR THE INSULIN PUMP WAS SET AT 70 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP ACTIVATED THE THRESHOLD SUSPEND WITH A SENSOR GLUCOSE READING OF LESS THAN 70 MG/DL WHERE THE ACTUAL BLOOD GLUCOSE LEVEL WAS 178 MG/DL. TROUBLESHOOTING WAS DONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726127 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG08M1S

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR