FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 10967590
·
Received December 8, 2020
Report
- Report Number
- 3013756811-2020-141081
- Event Type
- Malfunction
- Date Received
- December 8, 2020
- Date of Event
- November 30, 2020
- Report Date
- December 8, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613205
- PMA / PMN Number
- K201214
- 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 PUMP WAS INTERMITTENTLY HOT TO THE TOUCH WHEN CHARGING DESPITE BEING IN ROOM-TEMPERATURE CONDITIONS. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. ADDITIONALLY, AN OCCLUSION ALARM OCCURRED. THE CUSTOMER CLEARED THE ALARM TO RESOLVE THE ISSUE. ADDITIONALLY, THE INSULIN GAUGE WAS INACCURATE. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THE CUSTOMER¿S BLOOD GLUCOSE RANGED BETWEEN 160-337(MG/DL).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1433762 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |