FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 9316656
·
Received November 13, 2019
Report
- Report Number
- 3013756811-2019-79311
- Event Type
- Malfunction
- Date Received
- November 13, 2019
- Date of Event
- September 21, 2019
- Report Date
- November 13, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007288
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE WAKE BUTTON WAS INTERMITTENTLY DELAYED IN RESPONDING TO PRESSES AND MULTIPLE PRESSES IN VARIOUS DIRECTIONS WERE NECESSARY FOR DISPLAY TO ACTIVATE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 100-220 MG/DL. THE CUSTOMER APPLIED MORE PRESSURE TO THE WAKE BUTTON TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1108579 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |