BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3930882 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03765
    Event Type
    Injury
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 1 OPENED AND 1 USED ENLITE SENSOR SHOWED THAT THEY FUNCTIONED PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED CALIBRATION ERRORS AND DIFFERENCES BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. CUSTOMER'S SENSOR GLUCOSE WAS REMAINING AT 50 MG/DL AND BLOOD GLUCOSE WAS 66 MG/DL. LATER SHE TRIED TO CALIBRATE AND THE SENSOR GLUCOSE WAS AT 95 MG/DL. CUSTOMER WAS LIMITED TO TROUBLESHOOTING. THE BLOOD GLUCOSE READING WAS 199 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408606 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR