FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 8112170
·
Received November 28, 2018
Report
- Report Number
- 3013756811-2018-43093
- Event Type
- Malfunction
- Date Received
- November 28, 2018
- Date of Event
- November 20, 2018
- Report Date
- November 28, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007318
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 RESISTANCE WAS EXPERIENCED WHEN FILLING A CARTRIDGE. ADDITIONALLY, IT WAS REPORTED THAT THE CARTRIDGE LEAKED. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 240-257 MG/DL DURING THESE ISSUES. A NEW CARTRIDGE WAS LOADED TO ADDRESS BOTH ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 951831 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | INFUSION SET: AUTOSOFT 90, INSULIN: NOVOLOG |