BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3933468 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03792
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) ANALYSIS INSPECTED 1 OPENED OR USED ENLITE SENSORS AND PERFORMED BICARBONATE BUFFER TEST PER (B)(4). THE SENSORS FAILED FOR HIGH READINGS. ALSO FOUND A BENT CANNULA WHICH WAS UNABLE TO BE CONFIRMED IT WAS IN SAID CONDITION BECAUSE THE SENSOR WAS RETURNED OPENED OR 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 COMPLAINED ABOUT SENSOR READING DISCREPANCY. CUSTOMER STATED THAT HER INSULIN PUMP HAS BEEN ALARMING THRESHOLD SUSPEND AND HER GLUCOSE LEVEL IS NOT LOW. SHE REPORTS BLOOD GLUCOSE OF 101MG/DL WHILE THE SENSOR GLUCOSE SHOWS 54MG/DL WITH A PERCENT DIFFERENCE OF 46.5%. CUSTOMER STATED THAT SHE HAS CALIBRATED THE SENSOR MULTIPLE TIMES AND READINGS ARE STILL INCORRECT. DURING TROUBLESHOOT CUSTOMER REMOVED THE SENSOR AND IT WAS BENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410982 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG03SZ7

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR