FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3841824
·
Received May 30, 2014
Report
- Report Number
- 3004753838-2014-05636
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- August 4, 2013
- Report Date
- May 5, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AN INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT A PATIENT'S FATHER HAD CONTACTED THE DISTRIBUTOR AND CLAIMED THAT AFTER INSERTION ON (B)(6) 2013, THE PATIENT BLED AND EXPERIENCED PAIN; AT WHICH TIME, THE NURSE WITH THE PATIENT DID NOT SEE THE SENSOR WIRE UPON REMOVAL. THE PATIENT'S FATHER DID NOT REPORT ANY ADDITIONAL MEDICAL INTERVENTION TO THE DISTRIBUTOR AT THE TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319155 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS, PRODUCT CODE: MDS | MDS | DEXCOM, INC. | 9500-25 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Other |