FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3841908
·
Received May 30, 2014
Report
- Report Number
- 3004753838-2014-04676
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- May 3, 2014
- Report Date
- May 5, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). COMPLAINT DEVICE WAS RETURNED TO DEXCOM AND EVALUATED. THE REPORTED FAILURE WAS NOT CONFIRMED AND NO DEFECT WAS FOUND.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED LOW AUDIO OUTPUT (B)(6) 2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED. ADDITIONALLY, AT THE TIME OF THE CALL, PATIENT TESTED ALERT FUNCTIONALITY AND REPORTED ALERTS WERE NOT FUNCTIONING. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 318774 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649-PNK | 5134497 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other |