FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 4933203
·
Received July 22, 2015
Report
- Report Number
- 3004753838-2015-05983
- 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
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE DATA LOG WAS PROVIDED BY THE PATIENT. THE DATA WAS REVIEWED ON (B)(6) 2015 AND CONFIRMED THE REPORTED EVENT OF INTERMITTENT OUT OF RANGE.
Description of Event or Problem · 1
PATIENT'S HUSBAND CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT INTERMITTENT OUT OF RANGE SIGNAL ON (B)(6) 2015. THE PATIENT'S HUSBAND DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475871 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9438-05 | 5195674 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |