BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945580 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04366
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 2 OPENED AND USED ENLITE SENSORS SHOWED THAT THEY FUNCTIONED PROPERLY AND PASSED ALL FUNCTIONAL TESTING. HOWEVER, FOUND BOTH ENLITE SENSORS WERE RECEIVED WITH BENT CANNULA. UNABLE TO CONFIRM IF THE CUSTOMER RECEIVED IN SAID CONDITION DUE TO THE CUSTOMER RETURNED OPENED AND USED.

    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 RETURN 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 THAT HER BLOOD GLUCOSE WAS 196 MG/DL. CUSTOMER STATED THAT HER SENSOR WAS GIVING BAD SENSOR ALERTS AND IT WAS COMING LOOSE FROM THE BASE OF THE SENSOR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425050 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR