BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3852319 · Received June 5, 2014

    Report

    Report Number
    2032227-2014-02914
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-02911.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OVERNIGHT HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 600 MG/DL. SHE STATED THAT SHE HAD CHANGED OUT HER INFUSION SET AND WAS ADVISED NOT TO WEAR THE DEVICE FOR 5 DAYS. SHE WAS UNSURE WHETHER THE INSTRUCTIONS WERE FOR THE INSULIN PUMP OR SENSOR. THE CUSTOMER ALSO REPORTED THAT THE SENSOR DID NOT ADHERE TO THE INSERTION SITE PROPERLY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329343 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR