BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 4230875 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-29039
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    IT WAS REPORTED THE CUSTOMER'S CONTINUOUS GLUCOSE MONITORING SYSTEM WAS NOT ACCURATE. THE CUSTOMER STATED HER SENSOR GLUCOSE READING WOULD BE 300 MG/DL AND HER BLOOD GLUCOSE WOULD BE 38 MG/DL. THE CUSTOMER STATED COMMUNICATION WAS PROPERLY CONNECTED BETWEEN THE SENSOR AND INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713592 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR