BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4120144 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29328
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED/USED ENLITE SENSOR WAS TESTED AND IT 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

    IT WAS REPORTED THAT CUSTOMER IS RECEIVING CALIBRATIONS ERRORS. IT WAS REPORTED THAT THE SENSOR GLUCOSE READING WAS 82 BUT HER BLOOD GLUCOSE VALUE WAS 229 MG/DL. IT WAS STATED THAT THIS CAUSED THE INSULIN PUMP TO SUSPEND WHEN CUSTOMER IS NOT LOW. CUSTOMER CALIBRATED BUT RECEIVED A CALIBRATION ERROR, SHE CALIBRATED 15 MINUTES LATER AND RECEIVED A SECOND CALIBRATION ERROR FOLLOWED BY CHANGE SENSOR ALARM. SENSOR HAS BEEN INSERTED FOR A DAY. CUSTOMER WAS ADVISED TO REMOVE AND CHANGE OUT THE SENSOR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598831 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A G224U

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR