FDA Adverse Event
Malfunction
Summary report: N
G4 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 2882783
·
Received December 20, 2012
Report
- Report Number
- 3004753838-2012-00346
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Date of Event
- October 1, 2012
- Report Date
- November 21, 2012
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEXCOM, INC. AND FDA AGREED DURING A FACILITY INSPECTION THAT ANY POSSIBLE BROKEN SENSOR WIRE WAS A REPORTABLE EVENT, EVEN IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.
Description of Event or Problem · 1
DEXCOM TECHNICAL SUPPORT WAS CONTACTED VIA EMAIL ON (B)(4) 2012, TO REPORT A POTENTIAL BROKEN SENSOR. NO ADDITIONAL INFORMATION WAS PROVIDED. DEXCOM TECHNICAL SUPPORT ATTEMPTED TO COLLECT ADDITIONAL INFORMATION TO NO AVAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | G4 CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-25 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |