FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
MDR report key: 10320167
·
Received July 24, 2020
Report
- Report Number
- 3013756811-2020-76930
- Event Type
- Malfunction
- Date Received
- July 24, 2020
- Date of Event
- July 3, 2020
- Report Date
- July 24, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613205
- PMA / PMN Number
- DEN180058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE INTERMITTENT MALFUNCTION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 122-180 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY AND HAD AN ALTERNATE PUMP AVAILABLE FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 786347 | 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 | 26 YR |