BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4823016 · Received June 6, 2015

    Report

    Report Number
    2032227-2015-18120
    Event Type
    Malfunction
    Date Received
    June 6, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 19, 2015
    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

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE EXPERIENCED SENSOR ISSUES. THE CUSTOMER STATED THAT SHE RECEIVED THE LOST SENSOR ALERT MULTIPLE TIMES. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. AFTER TROUBLESHOOTING, THE CUSTOMER WAS ADVISED THAT THE SENSORS WOULD BE REPLACED. THE CUSTOMER FURTHER MENTIONED THAT SHE HAD EXPERIENCED A BENT CANNULA IN THE PAST. THE CUSTOMER ALSO STATED THAT THERE WAS AN INSTANCE IN WHICH THERE WAS NO CANNULA PRESENT AFTER REMOVING THE SENSOR. THE CUSTOMER AGREED TO RETURN BACK THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366949 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A D175U

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR