FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3697866
·
Received March 25, 2014
Report
- Report Number
- 3004753838-2014-07080
- Event Type
- Malfunction
- Date Received
- March 25, 2014
- Date of Event
- February 27, 2014
- Report Date
- February 27, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SUBSEQUENT TO THE INITIAL MDR, THE TRANSMITTER (PART 9438-01/SERIAL NO. (B)(4)), THAT WAS BEING USED WITH THE SENSOR DURING THE REPORTED EVENT OF INACCURATE BLOOD GLUCOSE LEVELS WAS RETURNED ON 04/15/2014. EVALUATION OF THE RETURNED TRANSMITTER DID NOT CONFIRM THE REPORTED EVENT.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT THE SENSOR WAS INACCURATE WHEN COMPARED TO FINGERSTICK VALUES ON (B)(6) 2014. PATIENT DID NOT REPORT ANY INJURIES OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174665 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-27 | 5128241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Other |