FDA Adverse Event
Malfunction
Summary report: N
T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 9278968
·
Received November 5, 2019
Report
- Report Number
- 3013756811-2019-77055
- Event Type
- Malfunction
- Date Received
- November 5, 2019
- Date of Event
- October 14, 2019
- Report Date
- November 5, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004545
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 A CARTRIDGE CHANGE ERROR OCCURRED DURING THE LOAD SEQUENCE. ADDITIONALLY, IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE AND THAT RESISTANCE WAS EXPERIENCED DURING THE FILL PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 170-320 MG/DL. REPORTEDLY, THE CUSTOMER PERFORMED A CARTRIDGE CHANGE AND CHANGED THE SYRINGE NEEDLE RESOLVING THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1075208 | T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 | 00852162004545 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |