Tandem Diabetes Care, Inc. is recalling approximately 1,380 battery-operated insulin pumps due to critical translation errors in the Czech language user guide. The guide incorrectly instructs users to ensure the infusion set is connected to their body when it should actually confirm the set is disconnected. This error could lead to unintended insulin delivery while setting up the device, potentially resulting in dangerously low blood sugar. The affected pumps were distributed internationally to the Czech Republic and Slovakia.
Incorrectly following the guide's instructions could cause the pump to deliver insulin while the user believes it is safe to connect, potentially leading to a hypoglycemic event (low blood sugar) which can cause dizziness, confusion, or loss of consciousness.
Recall #: Z-1636-2026. Distributed in Czech Republic and Slovakia.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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