FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5236590
·
Received November 19, 2015
Report
- Report Number
- 3004753838-2015-77370
- Event Type
- Malfunction
- Date Received
- November 19, 2015
- Date of Event
- October 26, 2015
- Report Date
- October 26, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT'S MOTHER CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM AND THE BLOOD GLUCOSE (BG) METER ON (B)(6) 2015. THE PATIENT'S SENSOR WAS INSERTED ON (B)(6) 2015. THE PATIENT'S MOTHER DID NOT REPORT INJURY OR MEDICAL INTERVENTION. IT WAS REPORTED THAT CALIBRATION WAS NOT PERFORMED CORRECTLY, WHICH IS CONSIDERED OFF-LABEL USE. THE DEXCOM G4® PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: A. DO NOT CALIBRATE IF THE OUT OF RANGE SYMBOL SHOWS IN THE STATUS AREA. B. DO NOT CALIBRATE IF THE GLUCOSE READING ERROR SYMBOL SHOWS IN THE STATUS AREA. C. DO NOT CALIBRATE IF YOUR BLOOD GLUCOSE VALUE IS BELOW 40 OR ABOVE 400 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 768440 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-27 | 5202467 | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |