BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942717 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04238
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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

    INSPECTED ONE OPENED AND USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFER TEST, PER SPECIFICATIONS. SENSOR FAILED PER SPECIFICATION, DUE TO LOW READINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED SENSOR ERROR, BEFORE THE TWO HOUR WARM UP PERIOD OF THE SENSOR. CUSTOMER STATED HE CLEARED THE ALARM, SELECTED NEW SENSOR, AND SENSOR STILL DIDN'T WORK. HE LET THE SENSOR IN FOR A FULL WARM UP AGAIN AND CALIBRATED. DURING THE NIGHT SENSOR KEPT PREDICTING HIGH THEN LOW. INSERTED A NEW SENSOR AND IT KEEPS PREDICTING LOW AND BLOOD GLUCOSE LEVEL WAS AT 150 MG/DL. IT TOOK THREE HOURS AFTER CALIBRATION SO THE SENSOR WILL READ A NORMAL RANGE. TROUBLESHOOTING WAS PERFORMED. CURRENT BLOOD GLUCOSE LEVEL WAS 202 MG/DL. THE TRANSMITTER TESTED FINE. SENSOR WAS NOT BENT. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418468 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B044U

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR