BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4173659 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38295
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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

    ONE OPENED AND USED SENSOR WAS INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. THE SENSOR FAILED PER SPECIFICATION DUE TO LOW READINGS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED ABOUT SENSOR READING DISCREPANCIES. CUSTOMER REPORTED THAT THE SENSOR STARTED TO READ LOW AFTER 1 DAY OF INSERTION. CUSTOMER ATTEMPTED TO CALIBRATE, TURNED SENSOR FEATURE OFF AND RECONNECTED OLD TO RESOLVE THE CALIBRATION ERRORS. BUT THE INSULIN PUMP WAS GIVING CALIBRATION ERROR AND CHANGE SENSOR ALERTS. CUSTOMER STATED THAT THERE WERE SEVERAL DIFFERENCES BETWEEN READINGS. SENSOR GLUCOSE READING WAS 50 AND 55 MG/DL AND BLOOD GLUCOSE LEVEL WAS 150 AND 154 MG/DL. THE THRESHOLD SUSPEND FEATURE IS SET UP AT 60MG/DL; TROUBLESHOOT TRIGGERED SEVERAL TIMES WITH READINGS OF 51MG/DL TO 58MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654985 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A G184U

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR