FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 14397269
·
Received May 13, 2022
Report
- Report Number
- 3013756811-2022-48605
- Event Type
- Malfunction
- Date Received
- May 13, 2022
- Date of Event
- April 19, 2022
- Report Date
- April 22, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004781
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
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, AND EVALUATION IS PERFORMED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A CARTRIDGE ALARM INTERMITTENTLY OCCURRED DURING BASAL DELIVERY WITH MULTIPLE CARTRIDGES. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 150-500 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2039640 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 | 00852162004781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Male |