FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM PEDIATRICS CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3971472
·
Received July 31, 2014
Report
- Report Number
- 3004753838-2014-25123
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Date of Event
- June 28, 2014
- Report Date
- July 7, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION OF THE RETURNED DEVICE AND REVIEW OF THE DATA LOG DID NOT CONFIRM THE REPORTED LOW AUDIO OUTPUT.
Description of Event or Problem · 1
PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO CLAIM LOW AUDIO OUTPUT PATIENT EXPERIENCED ON 6/28/2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED. ADDITIONALLY, DURING THE CALL, DEXCOM TECHNICAL SUPPORT ADVISED PATIENT'S FATHER TO TEST THE ALERT FUNCTIONALITY AND REPORTED ALERTS WERE FUNCTIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448480 | G4 PLATINUM PEDIATRICS CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT22430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |