FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 4617810
·
Received March 19, 2015
Report
- Report Number
- 3004753838-2015-02134
- Event Type
- Malfunction
- Date Received
- March 19, 2015
- Date of Event
- February 20, 2015
- Report Date
- February 23, 2015
- 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).
Additional Manufacturer Narrative · 1
(B)(4). THE COMPLAINT RECEIVER WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (9438-05/66W9M), USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON (B)(4) 2015. THE RETURNED COMPLAINT TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED, CONFIRMING THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.
Description of Event or Problem · 1
PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT PERMANENT OUT OF RANGE SIGNAL ON (B)(6) 2015. DEXCOM TECHNICAL SUPPORT ADVISED PATIENT'S FATHER TO PERFORM RESET ON DEVICE. THE PATIENT'S FATHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186206 | G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT22430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |