BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4183578 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40360
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 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

    INSPECTED 2 OPENED/USED ENLITE SENSORS AND PERFORMED BICARBONATE BUFFER TEST. BOTH SENSORS FAILED 1 OF 2 SENSORS FAILED DUE TO HIGH READINGS. 2ND SENSOR FAILED WITH LOW READING.

    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

    CUSTOMER REPORTED RECEIVING A SENSOR ERROR AND LOST SENSOR ALARM. THE CUSTOMER ALSO REPORTED A BUTTON ERROR ALARM HAD OCCURRED. CUSTOMER'S BLOOD GLUCOSE WAS 100 MG/DL. THE CUSTOMER ALSO STATES THE SENSOR WAS NOT FULLY INSERTED/FLAT AGAINST THE SKIN. CUSTOMER WAS ADVISED THE SENSOR MAY NOT BE WORKING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663882 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR