BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4170101 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37722
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. 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 THE CUSTOMER HAD DIFFERENCES BETWEEN THE SENSOR GLUCOSE AND THE BLOOD GLUCOSE READINGS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS ABOUT 140 MG/DL. CUSTOMER STATED THAT THE SENSOR GAVE HIM INCORRECT READINGS AND IS SAYING THAT HE IS UNDER 40 MG/DL. CUSTOMER STATED THAT THE PUMP WAS GOING INTO LOW SUSPEND AND TELLING HIM THAT HE IS UNDER 40 MG/DL WHEN HIS BLOOD GLUCOSE LEVEL WAS 140 GM/DL. CUSTOMER'S SENSOR GLUCOSE AND BLOOD GLUCOSE DIFFERENCE WAS NOT WITHIN AN ACCEPTABLE RANGE. CUSTOMER IS A LONG TIME SENSOR USER. IT WAS FOUND THAT THE CAL FACTOR WAS NOT WITHIN RANGE FOR OPTIMAL CALIBRATION. CUSTOMER DID NOT WANT TO TURN OFF THE SENSOR AND TURN IT BACK ON FOUR HOURS LATER. CUSTOMER TRIED TURNING IT OFF AND ON, BUT THE INTERSTITIAL SIGNAL WAS THE SAME. CUSTOMER WAS CURRENTLY AT WORK AND CANNOT DO IT DURING THE CALL. CUSTOMER CALIBRATES WITH TWO DIFFERENT METERS AND IS NOT ABOUT TO CHANGE THAT PROTOCOL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649045 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR