BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16704380 · Received April 7, 2023

    Report

    Report Number
    3004753838-2023-074791
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    March 11, 2021
    Report Date
    August 4, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000590
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). HEALTH EFFECT - CLINICAL CODE - E0514 THOROMBOSIS/THROMBUS. HEALTH EFFECT - CLINICAL CODE - F1202 - DISABILITY. DEXCOM WAS SERVED WITH A LEGAL ACTION AS A RESULT OF THE PATIENT¿S ALLEGED INJURY. THE REPORTER DID NOT PROVIDE A DESCRIPTION OR INFORMATION REGARDING THE CIRCUMSTANCES OF THE ALLEGED EVENT OR DETAILS OF THE ALLEGED INJURY OTHER THAN WHAT IS ALLEGED IN THE COMPLAINT. DEXCOM HAS PROVIDED TO FDA THE INFORMATION IT CURRENTLY HAS RELATING TO THIS ALLEGED ADVERSE EVENT. DEXCOM HAS REQUESTED FURTHER INFORMATION FROM THE PATIENT¿S PERSONAL INJURY LAWYER.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    LEGAL COUNSEL REPORTED TO DEXCOM THAT THE PATIENT¿S G6 RECEIVER ALLEGEDLY FAILED TO NOTIFY OR SOUND AN ALARM. IT WAS STATED THAT THE PATIENT SUFFERED SERIOUS INJURIES INCLUDING BUT NOT LIMITED TO LOSS OF CONSCIOUSNESS, ANKLE FRACTURES, A RIGHT TIBIA/FIBULA FRACTURE, AND DEEP VEIN THROMBOSIS. IT WAS REPORTED THAT THE INJURIES REQUIRED MULTIPLE SURGERIES, INPATIENT HOSPITAL CARE, AND REHABILITATION. ACCORDING TO THE REPORT, THE PATIENT HAS BEEN RENDERED PERMANENTLY DISABLED AND HAS SEVERE MOBILITY LIMITATIONS. DESPITE ADDITIONAL REQUESTS FOR INFORMATION, NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795182 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. STK-OR-001 00386270000590

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Hospitalization| O| S