BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4821226 · Received June 5, 2015

    Report

    Report Number
    2032227-2015-17963
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 17, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD A NEEDLE ANOMALY WITH THEIR SENSOR. IT WAS FOUND THE NEEDLE WAS MISSING WHEN THE CUSTOMER ATTEMPTED TO INSERT THE SENSOR. CUSTOMER'S BLOOD GLUCOSE WAS 240 MG/DL. THE CUSTOMER'S SENSOR WILL BE REPLACED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365415 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG0FNQ9

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR