FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 6064528
·
Received October 28, 2016
Report
- Report Number
- 3007981285-2016-17917
- Event Type
- Malfunction
- Date Received
- October 28, 2016
- Date of Event
- October 7, 2016
- Report Date
- October 7, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.
Additional Manufacturer Narrative · 1
THE REPORTED ISSUE COULD NOT BE CONFIRMED; HOWEVER, A DIFFERENT ISSUE WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT OUT OF RANGE ISSUES OCCURRED BETWEEN THE TRANSMITTER AND PUMP, WITH NO CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READINGS. THE CUSTOMER REPORTED A BLOOD GLUCOSE LEVEL OF 200 (MG/DL). THE CURRENT PUMP WILL CONTINUE TO BE USED FOR DIABETES MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714953 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |