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FDA-Device2026-04-01Class IIMISBRANDING

Tandem Diabetes insulin pumps recalled for Czech language guide translation errors

Tandem Diabetes Care
LABEL MIX UPNationwide distribution

Check your Tandem pump's Czech language guide

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.

  • 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.
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.

Sold states
International distribution in the countries of Czech Republic, Slovakia.
Affected count
1,380 units
Manufactured in
12400 High Bluff Dr, San Diego, CA, United States
Products
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).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1636-2026

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