BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE MMT-7008B

    MDR report key: 4170135 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37742
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED/USED ENLITE SENSOR WAS INSPECTED AND TESTED; IT FAILED PER SPECIFICATIONS WITH HIGH 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 ISSUES WITH SENSOR GLUCOSE VERSES BLOOD GLUCOSE DIFFERENCES. SENSOR GLUCOSE AND BLOOD GLUCOSE DIFFERENCE IS NOT WITHIN ACCEPTABLE RANGE. CUSTOMER'S CURRENT BLOOD GLUCOSE VALUE IS 289 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649263 SENSOR ENLITE MMT-7008B OZO OZO MEDTRONIC MINIMED MMT-7008B G224U

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR