BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16039911 · Received December 22, 2022

    Report

    Report Number
    3004753838-2022-240747
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    November 27, 2022
    Report Date
    August 8, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000866
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2022-240747 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ???/HOUR GLASS/NO READINGS/SENSOR ERROR IN STATUS BOX OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF LABEL USAGE OF THE DEVICE ON (B)(6) 2022. THE PATIENT STATED ON THE DAY THE SENSOR WAS INSERTED, THEY HAD A SENSOR ERROR. THEY HAD A SEIZURE AND WAS TREATED WITH AN UNSPECIFIED MEDICATION. AT THE TIME OF THE REPORT THE SAME DAY SHE WAS STABLE. DATA WAS PROVIDED FOR INVESTIGATION. THE PROBLEM COULD NOT BE CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED POST INVESTIGATION AS THE ALLEGATION WAS NOT FOUND. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. THE PATIENT EXPERIENCED A SEIZURE RELATED TO A PRE-EXISTING NEUROLOGICAL ISSUE AND THE ASSOCIATED MEDICATIONS. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2653544 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 NI 00386270000866

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other