FDA Adverse Event
Injury
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3713197
·
Received March 31, 2014
Report
- Report Number
- 3004753838-2014-11865
- Event Type
- Injury
- Date Received
- March 31, 2014
- Date of Event
- March 28, 2013
- Report Date
- April 1, 2013
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE DATA LOG FILE CONFIRMED THE REPORTED INACCURATE BLOOD READINGS FROM THE SENSOR. DATE OF MEDICAL INTERVENTION: N/A. EXTENT OF INJURY: THE PATIENT BEGAN TO CONVULSE UNTIL TREATED FOR THE LOW, BUT NO INJURY SUSTAINED. DESCRIPTION OF MEDICAL INTERVENTION: N/A. OTHER MEDICATIONS: UNKNOWN. CURRENT CONDITION OF CONSUMER: UNKNOWN.
Description of Event or Problem · 1
CONSUMER CONTACTED DEXCOM TO REPORT THE SENSOR GAVE INACCURATE BLOOD GLUCOSE READINGS. THE CONSUMER REPORTED THAT SHE BEGAN TO CONVULSE UNTIL TREATED FOR THE LOW. HOWEVER, NO INJURY SUSTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192203 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS, PRODUCT CODE: MDS | MDS | DEXCOM, INC. | 9500-27 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |