FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
MDR report key: 10817374
·
Received November 10, 2020
Report
- Report Number
- 3013756811-2020-122419
- Event Type
- Malfunction
- Date Received
- November 10, 2020
- Date of Event
- October 18, 2020
- Report Date
- November 10, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613205
- PMA / PMN Number
- DEN180058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT, AND SUBSEQUENTLY THE PUMP SHUTDOWN. DURING A FOLLOW-UP CALL, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING AN ALTERNATE WALL ADAPTER. CUSTOMER¿S BLOOD GLUCOSE VALUE RANGED FROM 140-159 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1284854 | T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |