BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3994100 · Received August 8, 2014

    Report

    Report Number
    2032227-2014-06612
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER CALLED REGARDING ISSUES WITH THEIR SENSOR ON THEIR INSULIN PUMP. THE ISSUE WAS THAT THE SENSOR GLUCOSE WAS A LOT LOWER THAN THE BLOOD GLUCOSE. THE PATIENT'S BLOOD GLUCOSE WAS AT 148 MG/DL. THE CUSTOMER WAS HELPED WITH TROUBLESHOOTING AND IT SEEMS THAT THE SENSOR GLUCOSE WAS NOT RESPONDING WELL TO THE CHANGES TO THE BLOOD GLUCOSE. THE CUSTOMER WAS INFORMED THAT CHANGES IN THE BLOOD GLUCOSE CAN RESULT IN INACCURATE CALIBRATIONS IN THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE POSITION OR ADVANCED PRESSURE IN WHICH THE SENSOR WAS IN COULD BE THE CAUSE OF THE ISSUE. THE CUSTOMER WAS ADVISED TO MONITOR THE SITUATION AND TO CALL US BACK IF THERE WERE ANY ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472039 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other