BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3943071 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04489
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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

    CUSTOMER REPORTED THAT THE SENSOR GAVE LOST SENSOR ALERTS AND NEVER WORKED. THE MOST RECENT BLOOD GLUCOSE READING WAS 184 MG/DL. CUSTOMER STATED THAT WHEN SHE REMOVED THE SENSOR FROM HER BODY THAT IT WAS BENT. SHE ALSO MENTIONED THAT SHE HAD PROBLEMS WITH THE SERTER DEVICE. SHE STATED THAT SHE MAY HAVE DEVELOPED SOME SCAR TISSUE AND THAT IT WAS DIFFICULT FOR HER TO FIND SPOTS ON HER BODY FOR THE SENSOR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418223 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008B E214U

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR