Tandem Diabetes Care, Inc.: Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from wit

Hazard

The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.

Details from the source

Reason for recall: The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event. Distribution: International distribution in the countries of Czech Republic, Slovakia. Quantity: 1,380 units Lot/code info: Version 7.8.1/ UDI: (01)008500066132625

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.