BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4223099 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47436
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    September 27, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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

    THREE OPENED AND USED SENSORS WERE INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. TWO OF THREE SENSOR CANNULAS WERE BROKEN. ONE REMAINING SENSOR PASSED WITH ACCURATE READINGS AND A HOOK WAS FOUND AT THE TIP OF THE SENSOR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE REMOVED ONE OF THE SENSORS AND THE CANNULA HAD DETACHED AND STAYED IN HIS BODY; CUSTOMER WAS ABLE TO PULL IT OUT. CUSTOMER STATED THAT HE HAD BEEN HAVING TROUBLE WITH THE SENSORS. CUSTOMER STATED THAT HE HAS RECEIVED CALIBRATION ERRORS, SENSOR ERRORS AND ONE OF THE SENSORS DID NOT GET FULLY INSERTED BECAUSE THE NEEDLE PORTION GOT STUCK. BLOOD GLUCOSE VALUE IS 283 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705612 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A G234U

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR