FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 10122860
·
Received June 5, 2020
Report
- Report Number
- 3013756811-2020-56486
- Event Type
- Malfunction
- Date Received
- June 5, 2020
- Date of Event
- March 14, 2020
- Report Date
- June 5, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007295
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 DURING THE FILL PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 120-145 MG/DL. A SYRINGE NEEDLE CHANGE WAS PERFORMED RESOLVING THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586010 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |