Tandem insulin pump Czech guide inverted a key connection instruction

Plain-English summary

Tandem Diabetes Care, Inc. is recalling Tandem insulin pumps running version 7.8.1. The pumps are battery-operated infusion pumps capable of basal and bolus delivery of insulin from a disposable cartridge through an infusion set into subcutaneous tissue, with timing and quantity programmed by the user. About 1,380 units were distributed in the Czech Republic and Slovakia. The FDA has classified this recall as Class II.

The Czech language user guide contained multiple translation errors. The most significant error 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.

Affected product carries UDI 008500066132625.

Users and clinicians can identify affected pumps by the software version above, and may contact Tandem Diabetes Care, Inc. for further information.

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 i

Manufacturer

Tandem Diabetes Care, Inc.

Category

Medical Device — Insulin pump

Hazard

• translation-error
• inverted-instruction
• unintended-insulin-delivery
• hypoglycemia-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distribution scope not specified by the agency.

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