FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6032033
·
Received October 15, 2016
Report
- Report Number
- 3004753838-2016-72789
- Event Type
- Malfunction
- Date Received
- October 15, 2016
- Date of Event
- September 17, 2016
- Report Date
- September 17, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THREE SENSOR WIRES WERE RETURNED FOR EVALUATION (LOT NUMBER 5211761). A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRES WERE MISSING FROM THE SENSOR POD AND HOUSING PUCK. DUE TO THE MISSING SENSOR WIRES THE SENSOR WIRE IS CONSIDERED DETACHED. THE REPORTED EVENT OF A DETACHED SENSOR WIRE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS UNKNOWN WHICH SENSOR IS THE SENSOR AT FAULT.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(6) 2016 , TO REPORT A DETACHED SENSOR WIRE THAT OCCURRED ON (B)(6) 2016. THE SENSOR INSERTION WAS AT THE ABDOMEN ON THE (B)(6) 2016. THERE WAS NO REPORT ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683370 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | 9500-27 | 5211761 | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |