BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3930890 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03781
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS CONTACTED BY OUTREACH. CUSTOMER STATED A PROBLEM OCCURRED WHEN SHE TESTED TWO SENSORS. CUSTOMER STATED HER BLOOD GLUCOSE WOULD BE HIGHER OR LOWER THEN THE CONTINUOUS GLUCOSE MONITORING. SINCE THIS EVENT, SHE IS NOT WEARING A SENSOR. CUSTOMER STATED SHE CALIBRATES FOUR TO FIVE TIMES PER DAY. RECOMMENDED TO CALIBRATE THREE TO FOUR TIME PER DAY, ADVISED MORE THAN FOUR TIMES WILL ONLY CONFUSE THE SENSOR. SHE ALSO MENTIONED HAVING ISSUES WITH LOW ALERTS. THE BLOOD GLUCOSE READING WAS 130MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408723 SENSOR ENLITE OZO OZO MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR