BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19377589 · Received May 22, 2024

    Report

    Report Number
    3004753838-2024-123008
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 24, 2024
    Report Date
    November 25, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM ¿ ADDITIONAL D9: DEVICE AVAILABILITY ¿ ADDITIONAL G3: DATE RECEIVED BY MANUFACTURER - ADDITIONAL H2: ADDITIONAL INFORMATION/DEVICE EVALUATION H3: DEVICE EVALUATED BY MANUFACTURER ¿ ADDITIONAL H6: MEDICAL DEVICE PROBLEM CODE - ADDITIONAL H6: TYPE OF INVESTIGATION - ADDITIONAL H6: INVESTIGATION FINDINGS - ADDITIONAL.

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2024-123008 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    CMPL-(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TRANSMITTER BATTERY ISSUE OCCURRED. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED. PERFORMANCE DATA WAS REVIEWED. A TRANSMITTER BATTERY ISSUE WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, SIGNAL LOSS OVER ONE HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE SIGNAL LOSS COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TRANSMITTER BATTERY ISSUE OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750519 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 17306156

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female