FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 7754336
·
Received August 6, 2018
Report
- Report Number
- 3013756811-2018-26553
- Event Type
- Malfunction
- Date Received
- August 6, 2018
- Date of Event
- July 15, 2018
- Report Date
- August 6, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER THE T:SLIM X2 USER GUIDE, THE RECOMMENDED PUMP SEPARATION DISTANCE FROM A WIFI ROUTER IS 2.9IN (0.073 M). NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT INTERMITTENT LOSS OF CONNECTION ISSUES OCCURRED BETWEEN THE TRANSMITTER AND THE PUMP. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. REPORTEDLY, THE LOSS OF CONNECTION INTERMITTENTLY OCCURRED WHEN THE CUSTOMER WAS NEAR A WIFI ROUTER. THE PUMP AND THE TRANSMITTER REGAINED CONNECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 593176 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | DEXCOM, INC. | 9438-06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |