Dexcom is replacing some of its handheld receivers linked to continuous glucose monitoring (CGM) systems because of a faulty speaker. Several devices failed to sound audio alarms for dangerous blood sugar levels.
The handheld receivers serve as an optional alternative to Dexcom’s smartphone app. They log sensor readings, show blood sugar trends, and provide alerts on their own touchscreen display.
The company reported receiving at least 112 complaints worldwide. These included 56 severe adverse events such as seizures, loss of consciousness, vomiting, and other symptoms related to low or high blood sugar. Dexcom confirmed all affected users have recovered.
The problem stems from defective foam or assembly errors. These flaws may cause the speaker to lose contact with the circuit board, resulting in missed audio alerts.
Despite this issue, the receivers still provide vibration and visual warnings. Dexcom also stated that the accuracy of the sensors remains unaffected.
Customers were first informed about the problem in mid-May. After an update was issued on June 3, the U.S. Food and Drug Administration (FDA) classified the recall as Class I, the most serious type.
More than two million devices have been distributed globally, although not all are affected. Dexcom is offering free replacements based on the device serial number.
The company advises users to test their speaker regularly, especially whenever they replace their receiver.
Earlier this year, Dexcom issued correction notices for the G6 receivers due to possible delays or missed alerts. That problem was resolved with a software update.
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