BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 6146574 · Received December 5, 2016

    Report

    Report Number
    2032227-2016-47446
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 6, 2016
    Report Date
    November 6, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTRODE WAS BENT. CUSTOMER'S BLOOD GLUCOSE WAS 113 MG/DL. DURING TROUBLESHOOTING, CUSTOMER MENTIONED THE SENSOR APPEARED DAMAGED OR RETRACTED. CUSTOMER WAS ADVISED THE SENSOR WILL BE REPLACED. CUSTOMER WILL NOT BE RETURNING THE SENSOR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797356 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008B

    Patients

    Seq Age Sex Outcome Treatment
    1