FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7851841
·
Received September 6, 2018
Report
- Report Number
- 3004753838-2018-103266
- Event Type
- Malfunction
- Date Received
- September 6, 2018
- Date of Event
- August 8, 2018
- Report Date
- October 19, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 00386270000293
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(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 HAD OCCURRED. NO PRODUCT WAS PROVIDED FOR EVALUATION; HOWEVER, DATA HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DATA INVESTIGATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 08/08/2018 THAT ON 08/08/2018 A LOSS OF CONNECTION HAD OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE 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 |
|---|---|---|---|---|---|---|---|
| 695005 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | N/A | 00386270000293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |