BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4202968 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42595
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    February 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: RELIABILITY ANALYSIS EVALUATED 1 OPENED/USED ENLITE-SENSOR AND PERFORMED VISUAL INSPECTION AND FAILED PER SPEC. FOUND CANNULA BENT. ALSO UNABLE TO PERFORM INSERTION TEST, DUE TO SENSOR BEING OPENED/USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS PUTTING THE NEW ENLITE SENSOR IN AND IT IS NOT BLINKING GREEN AT ALL. WHEN SHE DISCONNECTED IT FROM THE CHARGER, IT FLASHED. CUSTOMER STATED THAT RIGHT NOW IT IS NOT FLASHING WHEN CONNECTING TO THE SENSOR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 235 MG/DL. CUSTOMER REPORTED THAT THE TRANSMITTER DOES NOT BLINK WHEN CONNECTED TO THE SENSOR. CUSTOMER STATED THAT SHE PUT IT BACK ON THE CHARGER 3 TIMES AND IT IS CURRENTLY ON THE CHARGER. CUSTOMER STATED THAT SHE CAN HEAR IT CLICK BUT IT IS NOT BLINKING. CUSTOMER INQUIRED IF SHE CAN PUT THE NEW SENSOR IN THE SAME AREA. CUSTOMER WAS ADVISED TO INSERT IN AN AREA THAT IS 2 INCHES AWAY FROM HER CURRENT SITE. IT WAS FOUND THAT THE SENSOR WAS BENT. CUSTOMER FOUND A BENT CANNULA, WHICH CAN BE FROM THE SCAR TISSUE OR MUSCLE THAT IT WAS HITTING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682656 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A J283U

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR