FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8414599
·
Received March 12, 2019
Report
- Report Number
- 3004753838-2019-25299
- Event Type
- Malfunction
- Date Received
- March 12, 2019
- Date of Event
- February 3, 2019
- Report Date
- March 12, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). CATALOG # - CORRECTION "9438-06, STT-GF-004, 30386270000225"
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON (B)(6) 2019, A LOSS OF CONNECTION OCCURRED. A DATA INVESTIGATION WILL NOT BE PERFORMED AS SIGNAL LOSS UP TO ONE HOUR IS WITHIN SPECIFICATION. CONFIRMATION OF THE COMPLAINT WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 206066 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR, | PQF | DEXCOM, INC. | MT22719-1 | 5239802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |