FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7567380
·
Received June 4, 2018
Report
- Report Number
- 3004753838-2018-59994
- Event Type
- Malfunction
- Date Received
- June 4, 2018
- Date of Event
- May 7, 2018
- Report Date
- May 8, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE COMPLAINT RECEIVER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND IT PASSED. THE RECEIVER WAS ABLE TO BE CHARGED AND REBOOTED. THE RECEIVER LOG WAS DOWNLOADED, HARDWARE ERRORS WERE FOUND. THE RECEIVER CASE WAS OPENED AND THE INTERNAL INSPECTION PASSED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 05/08/2018, THAT ON (B)(6) 2018, THE RECEIVER DISPLAYED HWW. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS RETURNED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE ERROR ICON COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410215 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT20649-1 | 5219224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |