BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 4141869 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33621
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED TWO OPENED/USED ENLITE SENSORS AND PERFORMED TESTING. ONE OF TWO SENSORS FAILED PER SPECIFICATION DUE TO LOW READINGS. THE SECOND SENSOR PASSED PER SPECIFICATION WITH ACCURATE 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 BY THE CUSTOMER THAT THEIR BLOOD GLUCOSE LEVELS WERE ELEVATED DUE TO CALIBRATION ERRORS WITH HER SENSOR. CUSTOMER UPLOADED CALIBRATION INFORMATION TO SOFTWARE PROVIDED. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER IS USING TWO DIFFERENT METERS. ADVISED CUSTOMER TO ONLY USE ONE METER AND TO CALIBRATE THREE TO FOUR TIMES A DAY. BLOOD GLUCOSE LEVEL WAS 154 MG/DL AND DEVICE PROMPTED HER TO CHANGE SENSOR. ADVISED CUSTOMER TO DISCONTINUE USE AND SEND DEVICE IN FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621753 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C C284

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR