FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11881350
·
Received May 25, 2021
Report
- Report Number
- 3013756811-2021-55024
- Event Type
- Malfunction
- Date Received
- May 25, 2021
- Date of Event
- May 6, 2021
- Report Date
- May 25, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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 BEING PERFORMED BY TANDEM TECHNICAL SUPPORT, HOWEVER, THE CUSTOMER DECLINED TO REMOVE THE SITE. CUSTOMER CLEARED THE ALARM AND REPORTED THAT THE INFUSION SET WOULD BE CHANGED. CUSTOMER'S BLOOD GLUCOSE WAS 180-262 MG/DL AT THE TIME OF EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772285 | 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 | 53 YR | INFUSION SET: TRUSTEEL |