FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 14084988
·
Received April 12, 2022
Report
- Report Number
- 3013756811-2022-32763
- Event Type
- Malfunction
- Date Received
- April 12, 2022
- Date of Event
- February 28, 2022
- Report Date
- March 21, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- 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 AN ALTITUDE ALARM OCCURRED WHILE THE CUSTOMER WAS NOT OUTSIDE OF THE LABELED OPERATING ALTITUDE RANGE. REPORTEDLY, CUSTOMER CLEANED THE SPEAKER HOLES AND CLEARED THE ALARM. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 162-199 MG/DL..
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210633 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Male |