FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 8335839
·
Received February 13, 2019
Report
- Report Number
- 3013756811-2019-05231
- Event Type
- Malfunction
- Date Received
- February 13, 2019
- Date of Event
- January 14, 2019
- Report Date
- February 13, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 852162004439
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CARTRIDGE LEAKED. A CARTRIDGE CHANGE WAS PERFORMED TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED BETWEEN 210-230 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128306 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 | 852162004439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | INFUSION SET: AUTOSOFT 90, INSULIN: HUMALOG |