FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 4591170
·
Received March 11, 2015
Report
- Report Number
- 3004753838-2015-01888
- Event Type
- Malfunction
- Date Received
- March 11, 2015
- Date of Event
- February 14, 2015
- Report Date
- February 14, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). THE COMPLAINT RECEIVER DEVICE WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER DEVICE(9438-05/68E9P), USED WITH THE COMPLAINT RECEIVER DEVICE, 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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT PERMANENT OUT OF RANGE SIGNAL ON (B)(6) 2015. THE PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167745 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649-PNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |