BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3933453 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03891
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED SEVERAL CALIBRATION ERROR ALARMS AND A CHANGE SENSOR ALARM. CUSTOMER DECIDED TO LEAVE SENOR TO GET HELPLINE ASSISTANCE. DECIDED TO RECALIBRATE ONE MORE TIME AND THIS TIME THE INSULIN PUMP ACCEPTED DATA. CURRENT SENSOR GLUCOSE WAS 126 MG/DL AND BLOOD GLUCOSE LEVEL WAS 122 MG/DL. TROUBLESHOOTING FOR BAD SENSOR WAS PERFORMED. THE INSULIN PUMP'S HISTORY AND SENSOR AGE WAS VERIFIED. SENSOR INSERTED IN THE ABDOMEN. BAD SENSOR DID NOT OCCUR AFTER A SECOND CALIBRATION ERROR. CUSTOMER WAS ADVISED TO CALIBRATE ABOUT AN HOUR AFTER FIRST CALIBRATION ERROR. SENSOR SEEMS TO BE WORKING CORRECTLY NOW. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411146 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A D084

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR