FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 16294665
·
Received February 3, 2023
Report
- Report Number
- 3013756811-2023-15338
- Event Type
- Malfunction
- Date Received
- February 3, 2023
- Date of Event
- January 12, 2023
- Report Date
- February 3, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00850006613700
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE TANDEM USER GUIDE INSTRUCTS THE USER TO REMOVE ANY RESIDUAL AIR FROM THE CARTRIDGE. THE CARTRIDGE USER GUIDE CAUTIONS THAT INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE FILLING A CARTRIDGE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. IN ADDITION, A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 300 UNITS OF INSULIN DURING THE LOAD SEQUENCE. REPORTEDLY, THE CUSTOMER LOADED COLD INSULIN INTO THE CARTRIDGE AND WAS NOT PERFORMING THE AIR REMOVAL STEP. CUSTOMER RE-LOADED THE CARTRIDGE TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 233-325 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1985131 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 | 60383491 | 00850006613700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Female |