FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3932904
·
Received July 14, 2014
Report
- Report Number
- 3004753838-2014-05774
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Date of Event
- June 4, 2014
- Report Date
- June 16, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT ON (B)(6) 2014 PATIENT EXPERIENCED A BROKEN SENSOR WIRE. AT THE TIME OF THE EVENT PATIENT WAS UNABLE TO BEGIN CGM SESSION. PATIENT PROCEEDED TO REMOVE SENSOR FROM INSERTION SITE. UPON SENSOR REMOVAL, PATIENT REPORTED THAT THE SENSOR WIRE WAS PARTIALLY PROTRUDING FROM INSERTION SITE AND WAS SUCCESSFULLY REMOVED FROM BODY. PATIENT 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 |
|---|---|---|---|---|---|---|---|
| 411239 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-25 | 5131374 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |