FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11991296
·
Received June 14, 2021
Report
- Report Number
- 3013756811-2021-60549
- Event Type
- Malfunction
- Date Received
- June 14, 2021
- Date of Event
- May 23, 2021
- Report Date
- June 14, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS PERFORMED BY TANDEM TECHNICAL SUPPORT AND NO ISSUES WERE IDENTIFIED. CUSTOMER CHANGED SUPPLIES TO ADDRESS OCCLUSION ALARMS, AND RESUMED INSULIN DELIVERY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS IN THE 250-395 MG/DL RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 889842 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | INFUSION SET: AUTOSOFT XCINSULIN: HUMALOG| INFUSION SET: AUTOSOFT XCINSULIN: HUMALOG |