FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM
MDR report key: 5000752
·
Received August 13, 2015
Report
- Report Number
- 3004753838-2015-80502
- Event Type
- Malfunction
- Date Received
- August 13, 2015
- Date of Event
- July 21, 2015
- Report Date
- July 21, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED A PERMANENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT RECEIVER WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5201194), BEING USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON 10/19/2015. THE RETURNED TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 534586 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM | MDS | MDS | DEXCOM, INC. | MT22495 | 5201378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |