GLUCOSENSOR™ SENSOR REPLACEMENT POLICY
At GlucoSensor™, we are committed to providing reliable and accessible Continuous Glucose Monitoring (CGM) technology across Europe. As part of our ongoing commitment to quality and user satisfaction, we have established a clear sensor replacement policy to support users in the event of issues during the intended sensor lifespan.
GlucoSensor™ sensors are single-use, medical supplies designed for up to 10 days of use before disposal. To support our users, GlucoSensor™ has established a sensor replacement policy for instances where a sensor fails during its intended usage period. In compliance with applicable EU regulations, GlucoSensor™ may offer a replacement in cases where, following review, a sensor is determined to have malfunctioned within its intended usage period.
DEFINITIONS
The following definitions apply throughout this Sensor Replacement Policy:
- DiaX Medical B.V.: The authorized EU Importer and distributor of the GlucoSensor™ Continuous Glucose Monitoring (CGM) System. DiaX Medical is responsible for customer service, product distribution, support, and warranty handling within the European Union. DiaX Medical also operates the GlucoSensor™ website and mobile application.
- MicroTech Medical Inc.: The legal manufacturer of the GlucoSensor™ CGM System, including all sensor and transmitter hardware. MicroTech Medical is responsible for the device’s medical design, performance, CE certification, and conformity under EU medical device regulations.
- Lotus NL B.V.: The Authorized Representative (AR) of MicroTech Medical Inc. in the European Union. Lotus NL B.V. is responsible for regulatory liaison with EU authorities and for ensuring the manufacturer’s compliance with EU medical device legislation.
- Sensor: A GlucoSensor™ glucose monitoring sensor intended for single use, with a wear period of up to 10 days, applied to the user’s body for continuous glucose trend monitoring.
- Transmitter: A reusable hardware component of the GlucoSensor™ CGM System that connects to the sensor and communicates glucose data to the mobile application.
- User: Any individual who purchases and/or uses the GlucoSensor™ CGM System or requests customer support or product replacement under this policy.
1. CONDITIONS OF NON-REPLACEMENT
1.1 Exclusions due to user handling or external factors:
GlucoSensor™ will not replace sensors that become detached due to external factors or user handling that falls outside the recommended application and wear instructions. These include, but are not limited to:
- Bumping or physical impact
- Swimming in chlorinated pools
- Using chlorinated hot tubs or jacuzzis
- Not using the provided alcohol wipes or similar products before application
- Not using the provided overlay patches
- Wearing the sensor on unapproved areas of the body
1.2 Approved sensor placement locations:
The approved positions for wearing the GlucoSensor™ are on the abdomen or the backside of the upper arms. Sensors placed in non-approved locations on the body may not function properly. As such, GlucoSensor™ will not provide replacements for sensors worn on areas outside the approved placement sites.
1.3 Sensor detachment and adhesive policy:
GlucoSensor™ has thoroughly tested the adhesive strength of the sensor patch. Additionally, we provide two different overlay patches, both of which should be used to keep the sensor securely in place for its entire lifespan. GlucoSensor™ asserts that we have taken all reasonable steps to prevent the sensor from detaching without external force. Therefore, sensors that detach from the body under the above-mentioned conditions will generally not be reimbursed.
1.4 Individual assessment of non-replacement requests:
In line with the Website End-User License Agreement (Website EULA), App End-User License Agreement (App EULA), and General Delivery Conditions, DiaX Medical B.V., as the Importer and EU distributor, reserves the right to assess all sensor replacement requests individually. DiaX Medical is not responsible for sensor issues caused by improper placement, failure to follow instructions, or external factors. In accordance with EU medical device regulations, DiaX Medical will process such requests in line with its obligations as Importer and may forward relevant cases to the Manufacturer or Authorized Representative if necessary. MicroTech Medical Inc., as the legal manufacturer, bears no responsibility for adhesive-related issues or performance problems caused by user handling or off-label use.
2. GOODWILL REPLACEMENT POLICY
2.1 Non-defective sensor replacements:
For requests involving non-defective sensors (e.g., sensors removed due to user application errors), users will receive educational materials from our support team or the support webpage to help prevent future issues.
2.2 Case-by-case review of additional requests:
Requests for additional goodwill replacements beyond these limits will be reviewed individually by our Technical Support leadership team. DiaX Medical reserves the right to adjust these limits at its discretion. Any replacement provided under this section is not guaranteed and may be offered based on practical considerations. Such replacements do not establish any entitlement or expectation for future cases and should not be regarded as a binding precedent.
2.3 Non-replacement conditions: Sensors and transmitters affected by external factors such as physical impact, placement outside of approved sites, or environmental interference will not be eligible for replacement. Users are advised to follow all placement, maintenance, and usage guidelines provided by DiaX Medical. Any sensor replacements issued as goodwill do not imply an obligation on the part of DiaX Medical to provide future replacements under similar conditions.
3. WARRANTY-BASED REPLACEMENTS
3.1 Defective sensor replacements:
In cases where a sensor defect is confirmed, the replacement is subject to the terms outlined in the Product Warranty section of the General Delivery Conditions. The defective sensors will be evaluated based on evidence provided by the user (e.g., malfunction reports, photos, or sensor data), and a replacement will be processed in line with our warranty policies. The consumer acknowledges that DiaX Medical is solely responsible for processing warranty-based replacements, in accordance with the applicable provisions of the Returns and Refund Policy, App EULA and Website EULA. The user acknowledges and consents to the review of technical data transmitted via the App or shared by the user to determine whether sensor failure has occurred, in accordance with the Privacy Policy and applicable data protection laws.
3.2 Required information for warranty claims:
Users must provide additional information, such as the transmitter serial number and the sensor lot number, as part of the warranty claim. DiaX Medical B.V. may, in certain circumstances, request the return of the defective sensor for inspection.
4. REQUIRED INFORMATION FOR REPLACEMENT REQUESTS
4.1 Mandatory information for all requests:
For all sensor replacement requests, users must provide the following information:
- Transmitter serial number
- Sensor lot number
- Details of the issue encountered
- Any additional information as required by our Customer Support team for verification purposes, as governed by the Privacy Policy.
5. RIGHT TO MODIFY AND REVIEW CASES
5.1 Policy modifications:
GlucoSensor™ reserves the right to modify the conditions of this Sensor Replacement Policy as necessary to remain compliant with applicable EU regulations and to respond to the needs of our users. Any changes will be communicated via the GlucoSensor™ website, and users are encouraged to regularly review the policy. Notification of significant changes may be provided through the GlucoSensor™ website or, where applicable, by email, in accordance with the communication provisions of the Website EULA and other governing terms.
5.2 Case-by-case review:
Requests for sensor replacements that fall outside the specific provisions of this policy may be reviewed on a case-by-case basis. Such reviews will be conducted in accordance with the applicable terms of the Website EULA, App EULA, General Delivery Conditions, and Returns and Refund Policy. DiaX Medical B.V. reserves the right to determine whether a sensor qualifies for replacement and to make adjustments to this policy where appropriate, provided that such decisions remain compliant with applicable EU consumer protection legislation.
6. INTEGRATION WITH OTHER TERMS
6.1 Part of the total agreement:
This Sensor Replacement Policy forms an integral part of the broader contractual framework governing the use of GlucoSensor™ products and services. This framework includes, but is not limited to, the Website End-User License Agreement (Website EULA), App End-User License Agreement (App EULA), General Delivery Conditions, Privacy Policy, Legal Disclaimer for the App, Legal Disclaimer for the Website, and the Returns and Refund Policy.
This policy should be read in conjunction with the applicable disclaimers and terms, which together define the conditions of use, liability limitations, warranty scope, replacement eligibility, and applicable dispute resolution procedures. In the event of any inconsistency, the more specific document relevant to the issue shall prevail.
7. LIMITATIONS OF DATA ACCURACY DUE TO EXTERNAL FACTORS
The GlucoSensor™ CGM System, developed by MicroTech Medical Inc., may be affected by various external physiological or environmental factors that can impact sensor performance. These include, but are not limited to, sensor placement, hydration levels, skin condition, body temperature, user activity, or deviation from the provided instructions for use.
Users are required to confirm any unexpected, inconsistent, or critical glucose readings using a traditional fingerstick blood glucose test or another medically approved method before making treatment decisions. The GlucoSensor™ CGM System is not intended to serve as the sole basis for clinical decision-making.
DiaX Medical B.V., as the EU Importer, and MicroTech Medical Inc., as the legal manufacturer, expressly disclaim any liability for inaccurate glucose readings, health outcomes, or medical decisions that result from external conditions or improper sensor handling or placement outside the approved instructions for use.
8. LANGUAGE DISCLAIMER
This policy may be made available in multiple languages for the convenience of users across the European Union. In the event of any discrepancies, contradictions, or differences in interpretation between the English version and any translated version, the English version shall prevail and be considered the legally binding and authoritative version.
DiaX Medical B.V. accepts no responsibility for any misunderstandings, errors, or legal consequences arising from translation inaccuracies. For full legal clarity, users are advised to consult the English version or contact DiaX Medical directly.
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