FDA Adverse Event
Malfunction
Summary report: N
T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 9118575
·
Received September 25, 2019
Report
- Report Number
- 3013756811-2019-65451
- Event Type
- Malfunction
- Date Received
- September 25, 2019
- Date of Event
- September 12, 2018
- Report Date
- September 25, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004361
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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. THE CUSTOMER'S BLOOD GLUCOSE WAS 200-499 MG/DL. REPORTEDLY THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 914938 | T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 | 00852162004361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |