FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 16885148
·
Received May 8, 2023
Report
- Report Number
- 3013756811-2023-63962
- Event Type
- Malfunction
- Date Received
- May 8, 2023
- Date of Event
- April 11, 2023
- Report Date
- May 8, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. H3 OTHER TEXT : DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN O-RING WAS ON THE PNEUMATIC TAP. THE CUSTOMER WAS ABLE TO REMOVE THE O-RING FROM THE PUMP AND SUCCESSFULLY LOADED A NEW CARTRIDGE TO RESOLVE THIS ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 103-330 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639445 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female |