FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5554352
·
Received April 7, 2016
Report
- Report Number
- 3004753838-2016-06962
- Event Type
- Malfunction
- Date Received
- April 7, 2016
- Date of Event
- March 11, 2016
- Report Date
- March 11, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A SENSOR (SERIAL NUMBER (B)(4)/LOT NUMBER 5203019) WAS RETURNED FOR EVALUATION A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS DETACHED FROM THE SENSOR POD AND HOUSING PUCK. THE REPORTED EVENT OF A DETACHED SENSOR WIRE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IF IT UNKNOWN IF THE RETURNED SENSOR IS THE COMPLAINT SENSOR.
Description of Event or Problem · 1
PATIENT'S MOTHER CONTACTED DEXCOM ON (B)(6) 2016, TO REPORT A DETACHED 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 209698 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-25 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |