FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 13585937
·
Received February 23, 2022
Report
- Report Number
- 3013756811-2022-16269
- Event Type
- Malfunction
- Date Received
- February 23, 2022
- Date of Event
- January 11, 2022
- Report Date
- February 23, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00850006613021
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE NOT RETURNED
Description of Event or Problem · 0
IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN FILLING THE CARTRIDGE DURING THE LOAD SEQUENCE. CUSTOMER CHANGED THE CARTRIDGE TO RESOLVE THE ISSUE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 251-271 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1006319 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 | W0061897 | 00850006613021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | INFUSION SET: TRUSTEEL, INSULIN: NOVOLOG |