FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 4182916
·
Received October 17, 2014
Report
- Report Number
- 3004753838-2014-29463
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Date of Event
- August 2, 2014
- Report Date
- August 4, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT PATIENT EXPERIENCED DISCOMFORT DURING USE OF SENSOR ON (B)(6)2014. PATIENT'S MOTHER CLAIMED THAT AFTER HORSEBACK RIDING, PATIENT FELT "FIRE" TYPE PAIN AND SUBSEQUENTLY REMOVED SENSOR. DEXCOM TECHNICAL SUPPORT ADVISED PATIENT'S MOTHER TO USE TEGADERM TAPE TO HELP SUPPORT SENSOR POD DURING ACTIVITIES SUCH AS HORSEBACK RIDING. PATIENT'S MOTHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 662014 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-27 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR |