FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3961021
·
Received July 28, 2014
Report
- Report Number
- 3004753838-2014-24706
- Event Type
- Malfunction
- Date Received
- July 28, 2014
- Date of Event
- June 30, 2014
- Report Date
- June 30, 2014
- 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
(B)(6). DEXCOM REVIEWED RECEIVER DATA ON 7/15/2014. THE COMPLAINT OF INACCURATE READINGS IS CONFIRMED.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE METER ON 6/30/2014. 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 |
|---|---|---|---|---|---|---|---|
| 439573 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-27 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | PORPHYRIA| KEPPRA| AMOXICILLIN| LYME RELATED| THYROID |