Tandem insulin pumps recalled for Czech user guide translation errors
Tandem Diabetes Care insulin pumps distributed in the Czech Republic and Slovakia have translation errors in their Czech language user guide. The most serious error tells users to verify the infusion set is connected to the body when it should say the opposite—that it should NOT be connected. Following these incorrect instructions could cause unintended insulin delivery and dangerously low blood sugar.
From the FDA notice · Read the official notice ↗ · All Tandem Diabetes Care recalls
What to do
- If you use a Tandem pump and received a Czech language guide, do not follow the infusion set connection instructions in that guide.
- Contact Tandem Diabetes Care for corrected instructions or an updated guide.
- Verify your infusion set is NOT connected to your body before priming or testing your pump.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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).
- Sold in
- Nationwide
- Made for
- All ages
Details
- Units affected
- 1,380 units
- Illnesses reported
- None reported
- Manufactured in
- 12400 High Bluff Dr, San Diego, CA, United States
- Classification
- Class II
- Recall number
- Z-1636-2026
In the FDA's words
- Description
- 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). 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. Version 7.8.1/ UDI: (01)008500066132625 Distribution: International distribution in the countries of Czech Republic, Slovakia. Affected quantity: 1,380 units
- 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.
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