SFDA Addresses Dexcom Glucose Monitoring Device Defect, Confirms Limited Distribution in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) has identified a defect in some of the Dexcom Continuous Glucose Monitoring (CGM) devices. This issue prevents audio alerts from sounding when blood glucose levels fluctuate too low or too high.

The SFDA has confirmed that a limited number of these affected devices, specifically no more than 190, have been distributed within Saudi Arabia. In response, the authority has mandated that the company replace all faulty devices and withdraw them from the market. The SFDA has also implemented regulatory measures to prevent any further circulation of these units, prioritizing consumer health and safety.

The SFDA reiterates its commitment to continuously monitor reports concerning medical products to ensure their safety in the Saudi market. The authority stresses that it will take strict action against any practices that compromise consumer well-being.

The SFDA encourages anyone who encounters defects in medical devices or supplies to report them immediately through the unified call center at 19999 or by visiting the website of the National Center for Medical Devices and Supplies Reports: https://ade.sfda.gov.sa/Home/NcmdrReport