BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945838 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04742
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 19, 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
    NV
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFER TEST PER SPECIFICATION. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS. ALSO, FOUND CANNULA BENT UNABLE TO CONFIRM CUSTOMER RECEIVED SENSOR IN SAID CONDITION DUE TO CUSTOMER RETURNING SENSOR 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

    CUSTOMER REPORTED THAT SHE WHEN SHE PULLED THE SENSOR IT PULLED OUT AND IT LEFT A LITTLE PIECE IN HER. CUSTOMER STATED SHE WAS GETTING CALIBRATION ERRORS AND CALIBRATION ERRORS. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 256 MG/DL, TREATED WITH THE INSULIN PUMP. ALARM AND POSSIBLE CAUSES WERE EXPLAINED TO THE CUSTOMER. ALERT WAS VERIFIED. THE SENSOR WAS INSERTED ON JUNE 19, 2014, ON THE LEFT SIDE OF HER ABDOMEN. ALERT OCCURRED WHEN CUSTOMER WAS WATCHING TELEVISION. CUSTOMER WAS ADVISED TO CHANGE THE SENSOR DUE TO THE INSULIN PUMP ALL READY ALARMING TWO CALIBRATION ERRORS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425305 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR