BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4210889 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44845
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED ONE OPENED/USED ENLITE SENSOR AND PERFORMED TESTING. THE SENSOR PASSED 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

    IT IS REPORTED THAT A CUSTOMER HAS ISSUES REGARDING THEIR SENSOR DISPLAYING WRONG READINGS OF SENSOR AND BLOOD GLUCOSE. THE PATIENT'S BLOOD GLUCOSE WAS AT 465 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLE SHOOTING AND WAS INFORMED THAT THE SENSOR NEEDS TO BE REPLACED. THE CUSTOMER WAS SENT A NEW SENSOR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693254 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG08LT9

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR