RegulatoryOfficial

Slovenian regulator issues safe-use advice for continuous glucose monitoring systems

🇸🇮 JAZMP · Mon 09 Nov 2026

JAZMP reminds CGM users to follow manufacturers' instructions, cross-check unusual readings with a fingerstick meter and report suspected device problems, including near misses.

The Slovenian medicines and medical devices agency, JAZMP, has published recommendations for people who use continuous glucose monitoring (CGM) systems. It stresses correct use, close adherence to the instructions for use and awareness of the devices' limitations. The notice reads as a reminder rather than a new restriction, and it does not describe any specific incident or corrective action.

JAZMP explains that CGM systems measure glucose in interstitial fluid, whereas standard fingerstick meters measure glucose in capillary blood. A physiological time lag between the two can produce differences, which may be larger during rapid glucose changes, such as after a meal, during or after physical activity, or after insulin dosing. Sensor placement and other factors related to the system and its conditions of use can also affect accuracy. Some deviation is therefore expected and does not by itself indicate a malfunction, but repeated, unusual or marked discrepancies, especially when readings do not fit how the user feels, deserve attention.

The agency lists other problems that can arise: sensor malfunction, interrupted readings or lost connection between system components; alerts that fail or are absent when expected; difficulties applying, fixing or removing the sensor; and skin reactions, irritation or inflammation at the application site. Such events do not necessarily mean a device is non-conforming or that a serious complication has occurred, JAZMP says, but they should be handled in light of their circumstances and possible consequences.

Among its recommendations, JAZMP advises users to check readings with a capillary meter when CGM values do not match symptoms or seem implausible, and to heed system alerts and error messages. It also asks them to record the sensor serial number or lot number, for example by photographing the packaging before use, to support traceability. If a sensor is suspected of malfunctioning, users should not discard it but, where possible and safe, keep it with its packaging for a possible manufacturer investigation, following the manufacturer's guidance before returning it.

On reporting, JAZMP encourages users, patients and healthcare professionals to notify the agency of suspected serious incidents, serious risks and other irregularities, even where no serious deterioration in health occurred but one could have occurred without timely action. It separates routes for serious incidents, for serious risks or falsified or stolen devices, and for other non-conformities or breaches. Useful report details include manufacturer and model, serial or lot number, a description and timing of the problem, whether it recurred across sensors, comparative fingerstick values, circumstances, health consequences and any prior contact with the manufacturer. Users can consent to JAZMP passing their contact details to the manufacturer or another economic operator to help investigate.

What it means for your team

  • Manufacturers and authorised representatives of CGM systems may see more user-initiated contact and complaints in Slovenia, so complaint-handling and vigilance intake processes should be ready for them.
  • Traceability is a theme: users are being told to keep serial or lot numbers and retain suspect sensors, which supports investigations if those samples reach manufacturers.
  • Instructions for use and patient-facing materials should clearly cover interstitial versus capillary differences and when to confirm with a fingerstick, as JAZMP expects users to be aware of these limits.
  • Reports of repeated problems across several sensors are explicitly sought and could feed into the agency's view of design, performance or labelling shortcomings.

Official source: JAZMP ↗

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

More Regulatory All →