BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945774 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04702
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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.

    Additional Manufacturer Narrative · 1

    UNABLE TO CONFIRM ADHESIVE ANOMALY DUE TO TWO SENSORS WERE RETURNED OPENED AND USED.

    Description of Event or Problem · 1

    CUSTOMER STATED SHE HAS HAD ISSUES WITH THE SENSOR RECENTLY. CUSTOMER STATED THAT WHEN SHE IS GOING TO TAKE OFF THE SERTER WHEN INSERTING A NEW SENSOR THE WHOLE SENSOR COMES OFF, IT WILL NOT STICK TO HER BODY. CUSTOMER CLARIFIED THAT THE SENSOR DOES NOT GET STUCK IN THE SERTER. CUSTOMER STATED THAT HER SERTER HAS BEEN REPLACED AND NOW THINKS THE ISSUE IS HER BODY. CUSTOMER BELIEVES THAT THE ADHESIVE DOES NOT STICK TO HER BODY TYPE. CUSTOMER WAS ADVISED TO CHANGE THE SENSOR AND SEE IF THE SAME ISSUE OCCURS. TROUBLESHOOTING FOR TAPE NOT STICKING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 141 MG/DL. CUSTOMER DOES NOT USE LOTION OR SOAP TO PREP THE SITE. CUSTOMER DOES PERSPIRE HEAVILY. CUSTOMER WAS ADVISED TO NOT USE ALCOHOL ON SITE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426280 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B204U

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR