BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3954106 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04655
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 HER SENSOR GLUCOSE WAS READING 50 MG/DL AND HER BLOOD GLUCOSE WAS ACTUALLY 154 MG/DL. THE INSULIN PUMP ALSO ALARMED CALIBRATION ERROR TWICE AND THEN CHANGE SENSOR. CUSTOMER INSERTED THE SENSOR (B)(4) 2014 ON HER ABDOMEN USING THE SERTER. CUSTOMER STATED THE ALARM DID NOT OCCUR AFTER PERFORMING A FIND LOST SENSOR OR WAS THE RESULT OF THE FIRST CALIBRATION ATTEMPT. CUSTOMER WAS ADVISED THAT TWO CONSECUTIVE CALIBRATION ERRORS WILL LEAD TO A CHANGE SENSOR ALERT. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE AND CALL BACK IF ISSUE CONTINUES. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429912 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG02WYE

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR