FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 10619993
·
Received October 2, 2020
Report
- Report Number
- 3013756811-2020-108658
- Event Type
- Malfunction
- Date Received
- October 2, 2020
- Date of Event
- August 14, 2020
- Report Date
- October 2, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TANDEM USER GUIDE INSTRUCTS THE USER TO REMOVE ANY RESIDUAL AIR FROM THE CARTRIDGE. 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 THE INSULIN GAUGE WAS INTERMITTENTLY INACCURATE. REPORTEDLY CUSTOMER DID NOT PERFORM AIR REMOVAL PROCEDURE CORRECTLY PRIOR TO LOADING THE CARTRIDGES. CUSTOMER¿S BLOOD GLUCOSE RANGED FROM 220-280 MG/DL.. REPORTEDLY, THE CUSTOMER REPLACED THE CARTRIDGE AND CONTINUED INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1087860 | 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 | 15 YR | INSULIN: HUMALOG |