FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 8298653
·
Received February 1, 2019
Report
- Report Number
- 3013756811-2019-04568
- Event Type
- Malfunction
- Date Received
- February 1, 2019
- Date of Event
- January 11, 2019
- Report Date
- February 1, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PUMP USER GUIDE STATES DO NOT REUSE CARTRIDGES OR USE CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE, INC. OR REUSE OF CARTRIDGES MAY RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. THIS CAN CAUSE VERY LOW OR VERY HIGH BLOOD GLUCOSE. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER RE-USED A CARTRIDGE TO LOAD ON TO THE PUMP. CUSTOMER¿S BLOOD GLUCOSE WAS 349 MG/DL. REPORTEDLY, THE CUSTOMER LOADED A NEW CARTRIDGE SUCCESSFULLY AND RECEIVED AN ACCURATE FILL ESTIMATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 92280 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | M147488 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | INSULIN: NOVOLOG |