DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2024-260012
- Event Type
- Injury
- Date Received
- October 8, 2024
- Date of Event
- September 13, 2024
- Report Date
- October 8, 2024
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- K213919
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6: HEALTH EFFECT CLINICAL CODE - HEARING IMPAIRMENT.
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2024. ON THE SAME DAY, IT WAS REPORTED THAT THE PATIENT WAS AT THE HOSPITAL PREMISE FOR OUTPATIENT THERAPY AND THEY STARTED TO FEEL BAD AND FELT DISORIENTED. THE DOCTOR FROM THE THERAPY PUT THE PATIENT FOR EMERGENCY SINCE HE WAS SHOWING STROKE SYMPTOMS AND HIS BLOOD PRESSURE WAS 223/110. AT THAT TIME THE PATIENT COULDN¿T TALK AND NOR HEAR PROPERLY. AT THE ER THEY TOOK A BG READING WHICH WAS 56 MG/DL AND THE CGM READING WAS 110 MG/DL. THE PATIENT WAS TREATED WITH IV FLUID AND D50 (DEXTROSE). ON THE (B)(6) 2024 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE BG READING WAS 98 MG/DL. AT THE TIME OF THE REPORT THE PATIENT WAS FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636957 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-161 | 1724165001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | Hospitalization| O |