FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5123990
·
Received October 2, 2015
Report
- Report Number
- 3004753838-2015-61800
- Event Type
- Malfunction
- Date Received
- October 2, 2015
- Date of Event
- September 12, 2015
- Report Date
- September 12, 2015
- Manufacturer
- DEXCOM INC.
- Product Code
- MDS
- UDI-DI
- 00386270000125
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 AN INTERMITTENT OUT OF RANGE SIGNAL ON (B)(6) 2015. AT THE TIME OF CONTACT THE PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652933 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS, PRODUCT CODE:MDS | MDS | DEXCOM INC. | 9438-05 | 5201172 | 00386270000125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |