BEUDAMED
    FDA Adverse Event Summary report: N

    SENSOR ENLITE

    MDR report key: 3930869 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03774
    Date Received
    July 12, 2014
    Date of Event
    June 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
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED AND USED ENLITE SENSOR WAS INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. THE SENSOR FAILED PER SPECIFICATION DUE TO LOW 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 REPORTED HAVING ISSUES WITH THE SENSOR. CUSTOMER REPORTED HAVING CALIBRATION ERRORS. TROUBLESHOOTING WAS DONE FOR CALIBRATION ERRORS. CUSTOMER STATES ALARM DID NOT OCCUR SHORTLY AFTER PERFORMING A "FIND LOST SENSOR" OR INITIATION. CUSTOMER STATES SENSOR AND BLOOD GLUCOSE READINGS ARE OFF BY 100 POINTS OR MORE. CARELINK DATA SUGGEST THAT CUSTOMER IS NOT ADHERING TO CALIBRATION RECOMMENDATIONS. SENSOR WAS REMOVED AND DETERMINED THE SENSOR WAS BENT. BLOOD GLUCOSE LEVEL WAS 150 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408594 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A L213U

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR