BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3933455 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03795
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    April 11, 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
    OR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED SENSOR. PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    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 HE STARTED WITH SENSOR GLUCOSE READING OF 205MG/DL; CHECKED BLOOD GLUCOSE AND IT WAS NEAR THAT VALUE TOO. HE TOOK INSULIN TO LOWER BLOOD GLUCOSE AND SENSOR WAS NOT SHOWING THE GLUCOSE DECREASING; IT SUDDENLY SHOWED SENSOR GLUCOSE AT 51MG/DL. HE HAD TO TREAT WITH GLUCOSE TABLETS AND AFTER CHECKING BLOOD GLUCOSE HE WENT UP TO AROUND 210MG/DL. CUSTOMER STATED INSULIN PUMP REQUESTED A CALIBRATION. CALIBRATED AND RECEIVED A CALIBRATION ERROR AND THEN CHANGE SENSOR ALERT. CUSTOMER HAD TO REMOVE SENSOR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410447 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR