FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 10296156
·
Received July 20, 2020
Report
- Report Number
- 3013756811-2020-73937
- Event Type
- Malfunction
- Date Received
- July 20, 2020
- Date of Event
- June 27, 2020
- Report Date
- July 20, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 852162004439
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 MULTIPLE OCCLUSION ALARMS OCCURRED. DURING SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT, IT WAS CONFIRMED THAT THE OCCLUSION WAS RELATED TO THE CARTRIDGE. CUSTOMER CHANGED THE CARTRIDGE TO ADDRESS THE OCCLUSION ALARMS AND SUCCESSFULLY RESUMED INSULIN. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 190-220 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763564 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 | 852162004439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | INSULIN: HUMALOG, INFUSION SET: AUTOSOFT 90 |