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 mecha

Company / brand

Tandem Diabetes Care, Inc.

Product

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 within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).

Reason / 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.

Classification

Class II

Status

Ongoing

Distribution / sold at

International distribution in the countries of Czech Republic, Slovakia.

Recall initiated

2026-01-30

Code info

Version 7.8.1/ UDI: (01)008500066132625

Product quantity

1,380 units

Voluntary mandated

Voluntary: Firm initiated

City

San Diego

State

CA

Country

United States

Event id

98478

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