BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3894844 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03381
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED IN (B)(6) OF 2014. BLOOD GLUCOSE WAS 70 MG/DL AT THE TIME OF THE ISSUE. THE CUSTOMER REFUSED TROUBLESHOOTING. THE MEDTRONIC REPRESENTATIVE EXPLAINED THE CAUSES OF SENSOR GLUCOSE AND BLOOD GLUCOSE DISCREPANCIES. THE CUSTOMER STATED THAT THEY HAVE BEEN OVER CALIBRATING, WHICH CAUSED CALIBRATION ERRORS. ALSO, THE CUSTOMER STATED THAT THEY GET BENT, CRIMPED OR KINKED CANNULAS UPON REMOVAL FROM THE BODY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370147 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A H9231536

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization