VariSoft infusion set, Model Number 1002827
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.
US Nationwide distribution in the state of CA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0232-2024