FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 4870119
·
Received June 25, 2015
Report
- Report Number
- 3004753838-2015-31471
- Event Type
- Malfunction
- Date Received
- June 25, 2015
- Date of Event
- May 29, 2015
- Report Date
- May 29, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT NO AUDIO OUTPUT FROM THE RECEIVER THAT OCCURRED ON (B)(6) 2015. AT THE TIME OF CONTACT, THE PATIENT'S MOTHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412434 | G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT22430-BLU | 5197615 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |