FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 5821102
·
Received July 25, 2016
Report
- Report Number
- 3004753838-2016-22237
- Event Type
- Malfunction
- Date Received
- July 25, 2016
- Date of Event
- June 27, 2016
- Report Date
- June 28, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- OYC
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 ON 06/28/2016 TO REPORT A MISSING SENSOR WIRE THAT OCCURRED ON (B)(6) 2016. THE SENSOR INSERTION WAS AT THE ABDOMEN ON (B)(6) 2016. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
A SENSOR (LOT NUMBER 5211746) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS MISSING FROM THE SENSOR POD AND HOUSING PUCK. DUE TO THE MISSING SENSOR WIRE, THE SENSOR WIRE IS CONSIDERED DETACHED. THE REPORTED EVENT OF A MISSING SENSOR WIRE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS UNKNOWN IF THE RETURNED DEVICE IS THE COMPLAINT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471779 | T:SLIM G4 SYSTEM | OYC | OYC | DEXCOM, INC. | 9500-27 | NI | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |