BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4231792 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-36115
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 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

    RELIABILITY ANALYSIS INSPECTED THREE OPENED AND USED ENLITE SENSORS AND FOUND TWO OF THE THREE SENSOR NEEDLES WERE BENT AT THE SENSOR'S BASE. REMAINING SENSOR FOUND WITH NO NEEDLE. UNABLE TO CONFIRM ADHESIVE ANOMALY DUE TO THREE SENSORS BEING RETURNED OPENED AND USED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER SENSORS ARE NOT STICKING. CUSTOMER'S BLOOD GLUCOSE WAS 164 MG/DL. SHE STATED THAT PART OF THE NEEDLE FROM THE LAST SENSOR IS STILL INSIDE, BUT THE SENSOR FELL OFF HER BODY. TWO OTHER SENSORS CAME OFF WITH THE SERTER. CUSTOMER WAS ADVISED TO HOLD THE SERTER DOWN AGAINST HER SKIN FOR AT LEAST THIRTY SECONDS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715745 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR