BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 17560582 · Received August 16, 2023

    Report

    Report Number
    3004753838-2023-162588
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    June 12, 2023
    Report Date
    September 13, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT, 3004753838-2023-162588 IS NOT A SERIOUS INJURY AND IS BEING DOWNGRADED TO A MALFUNCTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. B1 ADVERSE EVENT AND/OR PRODUCT PROBLEM - CORRECTION TO REMOVE ADVERSE EVENT B2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT - CORRECTION TO REMOVE OTHER SERIOUS B5 DESCRIBE EVENT OR PROBLEM - CORRECTION H1 TYPE OF REPORTABLE EVENT - CORRECTION H2 CORRECTION H6 CODES: TYPE OF INVESTIGATION - CORRECTION H6 CODES: INVESTIGATION FINDINGS - CORRECTION H6 CODES: INVESTIGATION CONCLUSION - CORRECTION H10 CORRECTED DATA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. ON (B)(6) 2023, THE PATIENT'S MOTHER REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED, THE PATIENT EXPERIENCED HYPERGLYCEMIA AND "GASTRO VOMITING". THERE WAS NO TREATMENT MENTIONED. IT WAS DOCUMENTED THAT THE PATIENT WAS HOSPITALIZED FOR 3 DAYS. THERE WERE NO DETAILS DOCUMENTED ABOUT THE MEDICAL INTERVENTION, NOT ANY TREATMENT ADMINISTERED TO THE PATIENT. THERE WAS NO BG (BLOOD GLUCOSE) NOR CGM (CONTINUOUS GLUCOSE MONITOR) READINGS REPORTED DURING THE ENTIRE EVENT. AT THE TIME OF THE REPORT THE PATIENT WAS WELL. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE SUPPLEMENTAL MDR, UPON FURTHER REVIEW OF THE COMPLAINT RECORD, THE PATIENT EXPERIENCED HYPERGLYCEMIA WITH VOMITING WHILE NOT IN AN ACTIVE SENSOR SESSION. THIS REPORT, 3004753838-2023-162588 IS NOT A SERIOUS INJURY AND IS BEING DOWNGRADED TO A MALFUNCTION. IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896080 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Hospitalization| O TANDEM