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Slovenia flags SIBIONICS GS3-R app showing glucose in wrong units on Android

🇸🇮 JAZMP · Thu 05 Nov 2026

JAZMP says version 01.13.00.00 of the Android app displayed mg/dL instead of mmol/L; the manufacturer has issued a corrected release, 01.13.01.00.

The Slovenian medicines and medical devices agency, JAZMP, has told users of the SIBIONICS GS3-R continuous glucose monitoring system about a fault in how the companion mobile app displays measurement units. The app is made by Shenzhen SiSENSING Co., Ltd.

According to JAZMP, the distributor was informed on 4 November 2026 of cases in which glucose values appeared in mg/dL rather than mmol/L. The problem was tied to Android app version 01.13.00.00.

The agency warns that showing the wrong unit can lead users to misunderstand their glucose values and, as a result, make inappropriate treatment decisions. Based on the information received so far, no harm to users has been reported.

After being notified, the manufacturer fixed the fault and released corrected version 01.13.01.00, which is already available on Google Play. JAZMP asks users to check that the units displayed are correct and to update the app to the latest version. Anyone who finds a problem should contact the distributor or report the event to JAZMP.

What it means for your team

  • Manufacturers and distributors of connected glucose monitoring systems should confirm that unit settings and display logic are verified for each software release, particularly on Android.
  • Vigilance teams should check whether similar unit-display events have been received for this product and whether reporting obligations apply in other markets.
  • Distributors in Slovenia and elsewhere may need to prompt users to update to version 01.13.01.00 and to handle user reports of incorrect units.

Official source: JAZMP ↗

Article written by VigiEye from the official source (JAZMP). AI-assisted; check the source before acting.

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