BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942851 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04401
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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'S SENSOR GAVE A LOW ALERT. BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS NOT KNOWN. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S INSERTION SITE WAS ON THE ABDOMEN AND SCAR TISSUE WAS PRESENT. THE PRODUCT WAS ADHERING NORMALLY, ALCOHOL WAS USED TO PREPARE SITE AND THE SENSOR HAD BEEN STORED IN A DRAWER. IT WAS ALSO FOUND THAT THE CUSTOMER WAS NOT WASHING HANDS OR USING ALCOHOL BEFORE TAKING BLOOD SAMPLES. THE CUSTOMER WAS ALSO REPORTEDLY ADVISED TO WAIT 5 MINUTES BEFORE CONNECTING TRANSMITTER. ADDITIONALLY, THE CUSTOMER REPORTS THAT THE SENSOR GLUCOSE AND BLOOD GLUCOSE WERE IN LINE WITH ONE ANOTHER THAT DAY. THRESHOLD SUSPEND AND LOW ALERTS WERE STATED TO HAVE OCCURRED WITH RIGHT SIDE INSERTION, AS WELL AS PREMATURE END OF USABILITY OF THE SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419238 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR UNOMEDICAL INFUSION SET