BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4183583 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40366
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    A COMPLETE ANALYSIS AND TESTING OF THE 1 OPENED AND USED ENLITE SENSOR FOUND THE SENSOR FAILED PER SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DIFFERENCES BETWEEN HER BLOOD GLUCOSE AND SENSOR GLUCOSE READINGS. SHE STATED HER BLOOD GLUCOSE WOULD BE 207 MG/DL AND HER SENSOR GLUCOSE WOULD BE 54 MG/DL. SHE ALSO STATED HER INSULIN PUMP WOULD GO INTO THRESHOLD SUSPEND. SHE ALSO REPORTED A BAD SENSOR ALERT HAD OCCURRED. THE CUSTOMER'S SENSOR WILL BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664067 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG0725Z

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR