FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 9576181
·
Received January 10, 2020
Report
- Report Number
- 3013756811-2020-04247
- Event Type
- Malfunction
- Date Received
- January 10, 2020
- Date of Event
- December 21, 2019
- Report Date
- January 10, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007318
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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 THE BATTERY GAUGE WAS FLUCTUATING AND MULTIPLE POWER ALERTS OCCURRED. PUMP SHUT OFF. CUSTOMER COULD NOT RECALL IF THE ADAPTER WAS CHANGED DURING THIS EVENT. CUSTOMER CHARGED PUMP AND RELOADED CARTRIDGE TO RESOLVE THE ISSUES. CUSTOMER'S BLOOD GLUCOSE WAS 200-206 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39735 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |