FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 9311057
·
Received November 12, 2019
Report
- Report Number
- 3013756811-2019-76517
- Event Type
- Malfunction
- Date Received
- November 12, 2019
- Date of Event
- September 21, 2019
- Report Date
- November 12, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- 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 MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 140-400'S MG/DL. REPORTEDLY, THE PUMP SUPPLIES WERE CHANGED TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS RESUMED. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1105001 | 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 | 66 YR |