BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4192747 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41571
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    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 COMPLAINED ABOUT SENSOR READING DISCREPANCIES. CUSTOMER REPORTED THAT THE INSULIN PUMP IS GOING INTO THRESHOLD SUSPEND AND HER BLOOD GLUCOSE IS NOT LOW. CUSTOMER STATED THAT THE SENSOR GLUCOSE READING WAS 60 MG/DL AND THE BLOOD GLUCOSE VALUE WAS 128 MG/DL ANOTHER TIME HER BLOOD GLUCOSE WAS 219 MG/DL AND THE INSULIN PUMP GOT INTO THRESHOLD SUSPEND. CUSTOMER STATED THAT SHE FEELS THE MORE SHE CALIBRATES THE BETTER; SHE CALIBRATES EVERY TIME SHE CHECKED HER BLOOD GLUCOSE. LAST BLOOD GLUCOSE VALUE IS 235 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673021 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A E074U

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR