FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 8967609
·
Received September 5, 2019
Report
- Report Number
- 3013756811-2019-54172
- Event Type
- Malfunction
- Date Received
- September 5, 2019
- Date of Event
- August 13, 2019
- Report Date
- September 5, 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
Additional Manufacturer Narrative · 1
THE FAILURE INVESTIGATION HAS BEEN COMPLETED AND THE ALLEGED MALFUNCTION ALARM ISSUE WAS VERIFIED. ADDITIONALLY THE ALLEGED UNEXPECTED SHUTDOWN ISSUE WAS VERIFIED IN THE PUMP LOGS, HOWEVER, NO FAILURE WAS IDENTIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. SUBSEQUENTLY, THE PUMP SHUT OFF UNEXPECTEDLY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 190-250 MG/DL. REPORTEDLY THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 757685 | 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 | 33 YR |