BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3930865 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03771
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SENSOR WAS NOT FUNCTIONING PROPERLY. CUSTOMER STATED THAT SENSOR READING WAS IN THE 400S AND HER BLOOD GLUCOSE WAS 150 MG/DL. CUSTOMER REPORTED THE INSULIN PUMP ALARMED CALIBRATION ERROR. TROUBLESHOOTING WAS PERFORMED. VERIFIED ALARM IN HISTORY. THE SENSORS AGE WAS FOUR DAYS NINETEEN HOURS. THE SERTER WAS USED TO INSERT THE SENSOR. ALARM DID NOT OCCUR SHORTLY AFTER PERFORMING A FIND LOST SENSOR. CUSTOMER IS CALIBRATING AS INDICATED. CUSTOMER WAS ADVISED TO CHANGE SENSOR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408716 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR