FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10052274
·
Received May 13, 2020
Report
- Report Number
- 3013756811-2020-47858
- Event Type
- Malfunction
- Date Received
- May 13, 2020
- Date of Event
- April 21, 2020
- Report Date
- May 13, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER TANDEM'S USER GUIDE: 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REPORTED HAVING REUSED INSULIN FROM AN OLD CARTRIDGE TO REFILL A NEW ONE. CTS EDUCATED CUSTOMER THAT THIS WAS OFF LABEL USAGE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 334 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 516633 | 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 | 22 YR |