FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 4933199
·
Received July 22, 2015
Report
- Report Number
- 3004753838-2015-05978
- Event Type
- Malfunction
- Date Received
- July 22, 2015
- Date of Event
- June 26, 2015
- Report Date
- June 26, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT INTERMITTENT OUT OF RANGE SIGNAL ON (B)(6) 2015. THE PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475870 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9438-05 | 5197561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |