FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7931577
·
Received October 3, 2018
Report
- Report Number
- 3004753838-2018-117562
- Event Type
- Malfunction
- Date Received
- October 3, 2018
- Date of Event
- August 26, 2018
- Report Date
- September 5, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). MODEL #/CATALOG #/UDI # - CORRECTION "9438-05, STT-GL-004, (B)(4)".
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE COMPLAINT AND A ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT OF LOSS OF CONNECTION WAS CONFIRMED VIA DATA. THE ROOT CAUSE WAS DETERMINED TO BE THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772398 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9438-06 | 6007518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |