FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11047587
·
Received December 21, 2020
Report
- Report Number
- 3013756811-2020-148357
- Event Type
- Malfunction
- Date Received
- December 21, 2020
- Date of Event
- December 9, 2020
- Report Date
- December 21, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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. DURING SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT, THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE CUSTOMER DECLINED TO REMOVE THE INFUSION SET CANNULA FROM THE INFUSION SITE. CUSTOMER SUCCESSFULLY RESUMED INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS BETWEEN 231-250 MG/DL AT TIME OF ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1511732 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | INFUSION SET: AUTOSOFT XCINSULIN: HUMALOG |