FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3953685
·
Received July 23, 2014
Report
- Report Number
- 3004753838-2014-25043
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- June 25, 2014
- Report Date
- June 26, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL INFORMATION/DEVICE EVALUATION. EVALUATION OF THE RETURNED DEVICE DID NOT CONFIRM THE REPORTED INTERMITTENT AUDIO OUTPUT.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014, TO CLAIM INTERMITTENT AUDIO OUTPUT ON (B)(6) 2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED. ADDITIONALLY, DURING THE CALL, DEXCOM TECHNICAL SUPPORT ADVISED PATIENT'S MOTHER TO TEST THE ALERT FUNCTIONALITY AND REPORTED ALERTS WERE FUNCTIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 432399 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |