FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 7915903
·
Received September 27, 2018
Report
- Report Number
- 3013756811-2018-34675
- Event Type
- Malfunction
- Date Received
- September 27, 2018
- Date of Event
- September 13, 2018
- Report Date
- September 27, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004798499396
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE ACROSS MULTIPLE CARTRIDGES. CUSTOMER¿S BLOOD GLUCOSE WAS 220-260 MG/DL. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 754932 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 | 00852162004798499396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |