BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945826 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04726
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED AND USED SENSOR WAS INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. THE SENSOR PASSED WITH ACCURATE READINGS. THE CANNULA WAS FOUND BENT. IT COULD NOT BE CONFIRMED THAT THE CUSTOMER RECEIVED THE SENSOR IN SAID CONDITION AS THE SENSOR WAS 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 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 RECEIVED LOST SENSOR ALERTS ON HER INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE WAS AT 142 MG/DL. SHE REMOVED THE SENSOR AND STATED IT WAS NOT INSERTED AND WAS BENT COMPLETELY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425301 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A L193U

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR