FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 15656360
·
Received October 22, 2022
Report
- Report Number
- 3013756811-2022-115776
- Event Type
- Malfunction
- Date Received
- October 22, 2022
- Date of Event
- September 9, 2022
- Report Date
- October 22, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PER TANDEM USER GUIDE: ONLY USE HUMALOG® OR NOVOLOG® U-100 INSULIN, AS ANY LESSER OR GREATER CONCENTRATION CAN RESULT IN SERIOUS HEALTH CONSEQUENCES. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 180-270 MG/DL. REPORTEDLY, THE CUSTOMER IS USING OFF LABEL INSULIN FIASP. TANDEM TECHNICAL SUPPORT (CTS) EDUCATED THE CUSTOMER ON INSULIN LABELING. THE CUSTOMER CHANGED THE INFUSION SET AND CARTRIDGE PRIOR TO THE REPORT WITH CTS. NO ISSUES WERE OBSERVED WITH THE CARTRIDGE OR INFUSION SET. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2547638 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | INSULIN TYPE: FIASPINFUSION SET: AUTOSOFT 30 |