BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 4192753 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41582
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED/USED SENSOR AND PERFORMED BICARBONATE BUFFER TEST PER SPECIFICATION. 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

    THE CUSTOMER REPORTED THAT THE HE HAD SENSOR DIFFICULTIES. CUSTOMER STATED THAT SENSOR READING WAS OVER 400 MG/DL AND METER READING OF 46 MD/DL. CUSTOMER STATED HE ENTERED IT AND GOT CALIBRATION ERROR, HE REQUESTED SECOND CALIBRATION AND RECEIVED ANOTHER CALIBRATION ERROR AND CHANGE SENSOR. CUSTOMER TRIED TO RESTART AND GOT A SENSOR ERROR AND HE CHANGED THE SENSOR. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 54 MG/DL. CUSTOMER TREATED WITH FRUIT AND SANDWICH. ADVISED THE CUSTOMER THE SENSOR WOULD BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673034 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C H144

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR