BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 4151548 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35124
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 1 OPENED AND USED ENLITE SENSOR, THE SENSOR FAILED PER SPECIFICATIONS DUE TO HIGH READINGS.

    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 A CHANGE SENSOR ALARM AFTER CHANGING THE SENSOR. CUSTOM WAS UNABLE TO GET CLEAR SENSOR READINGS DUE TO SENSOR AND CAL ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 35 MG/DL. CUSTOMER TREATED WITH CAKE FROSTING AND DECLINED TROUBLESHOOTING FOR BAD SENSOR ALERT. BAD SENSOR ALERT OCCURRED AFTER A 2ND CONSECUTIVE CAL ERROR. CUSTOMER WAS ADVISED TO REMOVE AND CHANGE OUT THE SENSOR. CUSTOMER WAS ABLE TO RUN A TEST PLUG PROCEDURE AND THE PROCEDURE PASSED. CUSTOMER WAS ADVISED THAT THE SENSOR MAY NOT BE WORKING, DISLODGED, BENT, RETRACTED, OR DAMAGED. CUSTOMER REMOVED AND REPLACED THE SENSOR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633473 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR