BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 17547528 · Received August 15, 2023

    Report

    Report Number
    3004753838-2023-160595
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    July 18, 2022
    Report Date
    August 16, 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).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT OF A SERIOUS INJURY WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE SERIOUS ADVERSE EVENT WAS NOT RELATED TO THIS SPECIFIC EVENT. THE REPORTED ADVERSE EVENT IS BEING REPORTED UNDER MFR NUMBER 3004753838-2023-162588. THIS REPORT 3004753838-2023-160589 REMAINS AN REPORTABLE EVENT WITHOUT A SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. APPROXIMATELY ON (B)(6) 2022, THE PATIENT EXPERIENCED HYPERGLYCEMIA, NO BLOOD GLUCOSE READING WAS REPORTED. NO TREATMENT WAS DOCUMENTED. IT WAS REPORTED THAT THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL WITH DIABETIC KETOACIDOSIS, IT IS NOT CLEAR HOW THIS WAS RELATED TO THE EVENT AND TO THIS DEXCOM MALFUNCTION. IT WAS DOCUMENTED THAT THE PATIENT WAS HOSPITALIZED 3 TIMES, ONCE THE PATIENT WAS JUST KEPT AT THE HOSPITAL OVERNIGHT, ANOTHER TIME THE PATIENT WAS HOSPITALIZED FOR 3 DAYS (THIS RECORD) AND A THIRD TIME THAT THE REPORT COULDN´T REMEMBER. THERE WERE NO DETAILS DOCUMENTED ABOUT THE MEDICAL INTERVENTION, NOT ANY TREATMENT ADMINISTERED TO THE PATIENT. THERE WAS NO BG NOR CGM READINGS REPORTED DURING THE ENTIRE EVENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994392 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Other| H TANDEM