FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 9244611
·
Received October 28, 2019
Report
- Report Number
- 3013756811-2019-71453
- Event Type
- Malfunction
- Date Received
- October 28, 2019
- Date of Event
- October 5, 2019
- Report Date
- October 28, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004781
- 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 IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT INTERMITTENT CARTRIDGE ALARMS (ALARM 19) OCCURRED WITH MULTIPLE CARTRIDGES. WHILE LOADING THE CARTRIDGES RESISTANCE WAS MET. CUSTOMER CONTINUED TO USE PUMP AND MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE WAS 130-147 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1039616 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 | 00852162004781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |