DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2023-160589
- Event Type
- Malfunction
- Date Received
- August 15, 2023
- Date of Event
- July 15, 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
(B)(4). THIS REPORT, 3004753838-2023-160589 IS NOT A SERIOUS INJURY AND IS BEING DOWNGRADED TO A MALFUNCTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
(B)(4). E1 INITIAL REPORTER FIRST NAME - (B)(6). E1 INITIAL REPORTER CITY - (B)(6).
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS.
SUBSEQUENT TO THE SUPPLEMENTAL MDR, UPON FURTHER REVIEW OF THE COMPLAINT RECORD, THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE NOT IN AN ACTIVE SENSOR SESSION. THIS REPORT, 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 THE SIGNAL LOSS WAS RELATED TO THE MOBILE APPLICATION. DATA WAS RECEIVED BUT DOES NOT REFLECT FULL INVESTIGATION WINDOW. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
SUBSEQUENT TO THE INITIAL MDR, CLARIFICATION WAS RECEIVED ON 08/14/2023. IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. ON 07/15/2023, THE PATIENT'S MOTHER REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED AND ON 07/17/2023, THE PATIENT EXPERIENCED HYPERGLYCEMIA, ELEVATED KETONES OF 4.2 MMOL/ AND VOMITING. IT WAS DOCUMENTED THAT THE PATIENT WAS TRANSPORTED TO THE ED (EMERGENCY DEPARTMENT). THERE WAS NO TREATMENT MENTIONED. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL WITH DIABETIC KETOACIDOSIS. OF NOTE, THE SENSOR REPORTEDLY FAILED PRIOR TO THE PATIENT EXPERIENCING HYPERGLYCEMIA. 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.
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. ON (B)(6) 2023, THE PATIENT EXPERIENCED HYPERGLYCEMIA, NO BLOOD GLUCOSE READING WAS REPORTED, AND ELEVATED KETONES OF 4.2 MMOL/L. 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 (THIS RECORD), ANOTHER TIME THE PATIENT WAS HOSPITALIZED FOR 3 DAYS 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. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1198728 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Female | Hospitalization| O | TANDEM |