BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4233569 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48923
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. 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'S SENSOR GLUCOSE AND BLOOD GLUCOSE READING VALUES WERE OVER 100 POINTS OFF. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 388 MG/DL BUT HER SENSOR GLUCOSE WAS 259 MG/DL. SHE ALSO REPORTED THAT THE CANNULA WAS BENT AND RECEIVED CALIBRATION ERRORS WHEN SHE REMOVED THE SENSOR. THE PRODUCT WILL BE RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715281 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG08PD2

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR