BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 3930681 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03745
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE INSERTED A SENSOR ON THE NIGHT BEFORE AND GOT THE FLASHING LIGHT; STARTED NEW SENSOR IN THE MORNING BUT RECEIVED A SENSOR ERROR ALERT. BLOOD GLUCOSE READING IS 130 MG/DL. DURING TROUBLESHOOT, CUSTOMER STATED THAT SENSOR IS FULLY INSERTED AND THE SENSOR ERROR ALERT HAPPENED AT THE INITIALIZATION. TOWARDS THE END OF THE TROUBLESHOOTING CUSTOMER CALIBRATED SUCCESSFULLY. CUSTOMER INQUIRED ABOUT THE IMPACT OF USING EXPIRED SENSORS. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408766 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C K193

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR