FDA Adverse Event
Injury
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3872094
·
Received June 13, 2014
Report
- Report Number
- 3004753838-2014-05681
- Event Type
- Injury
- Date Received
- June 13, 2014
- Date of Event
- May 13, 2014
- Report Date
- May 13, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 THEY WERE CONTACTED BY A PATIENT WHO, UPON SENSOR POD REMOVAL, STATED THAT SENSOR WIRE REMAINED LEFT BEHIND AT INSERTION SITE. AT THE TIME OF THE CALL WITH DEXCOM TECHNICAL SUPPORT, THE INTERNATIONAL DISTRIBUTOR STATED THAT NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED.
Description of Event or Problem · 1
AN INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 THEY WERE CONTACTED BY A PATIENT WHO, UPON SENSOR POD REMOVAL, STATED THAT SENSOR WIRE REMAINED LEFT BEHIND AT INSERTION SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349292 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS, PRODUCT CODE: MDS | MDS | DEXCOM, INC. | 9500-35 | 5095221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |