FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 4806218
·
Received May 29, 2015
Report
- Report Number
- 3004753838-2015-04380
- Event Type
- Malfunction
- Date Received
- May 29, 2015
- Date of Event
- May 4, 2015
- Report Date
- May 4, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT TRANSMITTER WAS NOT RETURNED TO DEXCOM. THE RECEIVER ((B)(4) LOT NUMBER 5191143), BEING USED WITH THE COMPLAINT TRANSMITTER, WAS RETURNED ON (B)(4) 2015. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING COULD NOT BE PEFORMED DUE A HARDWARE ERROR ICON BEING DISPLAYED ON THE RECEIVER SCREEN. THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE SIGNAL WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE COMPONENT IN THE RECEIVER'S PRINTED CIRCUIT BOARD.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT AN INTERMITTENT OUT OF RANGE SIGNAL ON (B)(6) 2015. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350631 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9438-05 | 5195666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |