BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4182678 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39670
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    January 19, 2014
    Report Date
    January 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED 2 OPENED/USED PARATIL ENLITE SENSORS AND FOUND 1 OF 2 SENSORS WITH NEEDLE BENT INSIDE SENSOR BASE. UNABLE TO CONFIRM CUST RECEIVED SENSOR IN SAID CONDITION DUE TO CUSTOMER RETURNED OPENED/USED PERFORMED BICARBONATE BUFFER TEST DOP114-830 REMAINING SENSOR AND SENSOR PASSED PER SPEC. WITH ACCURATE READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 198 MG/DL. THE CUSTOMER REPORTED HAVING ISSUES WITH THE SENSOR GLUCOSE LEVELS READING BEING DIFFERENT FROM THE BLOOD GLUCOSE LEVELS READING. THE CUSTOMER ALSO REPORTED THAT THE THRESHOLD SUSPEND FEATURE OF THE INSULIN PUMP ACTIVATED EVEN THOUGH IT WAS NOT SUPPOSED TO. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661200 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A K083U

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR