BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 5149029 · Received October 14, 2015

    Report

    Report Number
    2032227-2015-56743
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 15, 2015
    Report Date
    August 24, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS PERFORMED ON ONE OPENED AND USED ENLITE SENSOR FOUND THE SENSOR CANNULA WAS RETRACTED INSIDE OF THE SENSOR BASE, NO BROKEN OR MISSING PARTS WERE OBSERVED DURING OUR ANALYSIS. UNABLE TO CONFIRM IF HE CUSTOMER RECEIVED THE SENSOR DAMAGED DUE TO THE SENSOR WAS RETURNED OPENED AND USED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A SENSOR ANOMALY. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN MG/DL. THE CUSTOMER STATED THAT AFTER PUNCTURING THE ENLITE SENSOR AND WHEN THE TRANSMITTER WAS CONNECTED TO THE SENSOR , GREEN LIGHT DID NOT FLASH 6 TIMES. THE CUSTOMER REMOVED THE ENLITE SENSOR AND IT WAS FOUND THAT THERE WAS NO ELECTRODE. IT WAS CONFIRMED THAT THE PATIENT WILL VISIT THE MEDICAL CENTER WITH THE REPORTED DEVICE AT THE NEXT VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681064 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1