FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3960635
·
Received July 28, 2014
Report
- Report Number
- 3004753838-2014-24700
- Event Type
- Malfunction
- Date Received
- July 28, 2014
- Date of Event
- June 28, 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.
Additional Manufacturer Narrative · 1
(B)(4).
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 (B)(6) 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 |
|---|---|---|---|---|---|---|---|
| 438007 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-27 | 5135336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |