BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4201396 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42666
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    THREE OPENED AND USED SENSORS WERE INSPECTED AND TWO OF THREE WERE FOUND WITH COMPLETE ELECTRODES. THE SENSOR PASSED PER INSPECTION AND NO ANOMALY WAS NOTED DURING TESTING. THE REMAINING ELECTRODE WAS DETACHED IN THE ADHESIVE AREA. ANALYSIS NOT REQUIRED DUE TO THE CUSTOMER NOT RETURNING THE INSERTION NEEDLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD TO GO TO THE EMERGENCY ROOM. THE CUSTOMER FOUND THAT THE SENSOR WAS NOT LINKING TO THE PUMP. WHEN THE CUSTOMER CHANGED THE INFUSION SITE, THE CUSTOMER THOUGHT THE WIRE WAS STILL IN HIM. THE CUSTOMER ALSO STATED THE CANNULA WAS NOT PRESENT AND BELIEVED IT TO BE AN ISSUE WITH THE SENSOR. THE CUSTOMER'S BLOOD GLUCOSE WAS 55 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683324 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization