FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3891081
·
Received June 24, 2014
Report
- Report Number
- 3004753838-2014-22960
- Event Type
- Malfunction
- Date Received
- June 24, 2014
- Date of Event
- May 28, 2014
- Report Date
- June 2, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED PERMANENT LOSS OF ANTENNA THE ROOT CAUSE WAS DETERMINED TO BE A FAILED TRANSMITTER.
Description of Event or Problem · 1
INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT AN OUT OF RANGE SIGNAL ON (B)(6) 2014. INTERNATIONAL DISTRIBUTOR DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367733 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9438-01 | 5086235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other |