FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11365325
·
Received February 23, 2021
Report
- Report Number
- 3013756811-2021-22754
- Event Type
- Malfunction
- Date Received
- February 23, 2021
- Date of Event
- January 31, 2021
- Report Date
- February 23, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613779
- 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 AN OCCLUSION ALARM OCCURRED; CAUSE WAS UNKNOWN DUE TO CUSTOMER RESOLVING ISSUE PRIOR TO CONTACTING TANDEM TECHNICAL SUPPORT. ADDITIONALLY, IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. REPORTEDLY, CUSTOMER DECLINED FURTHER TROUBLESHOOTING AND REVERTED TO AN ALTERNATE PUMP FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE WAS BETWEEN 200-254 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265338 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |