FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3945098
·
Received July 18, 2014
Report
- Report Number
- 3004753838-2014-25017
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 21, 2014
- Report Date
- June 22, 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 NO AUDIO OUTPUT. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE G4 SPEAKER ASSEMBLY ASY000016.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO CLAIM NO AUDIO OUTPUT ON (B)(6) 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 TO TEST THE ALERT FUNCTIONALITY AND REPORTED ALERTS WERE NOT FUNCTIONAL, BUT DEVICE DID VIBRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421285 | G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT22430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |