GLUCOSENSOR™ SENSOR REPLACEMENT POLICY
At GlucoSensor™, we are dedicated to expanding access to our life-changing Continuous Glucose Monitoring (CGM) technology throughout Europe. As we grow, we remain committed to treating our users fairly and ensuring a positive experience with GlucoSensor™.
GlucoSensor™ sensors are single-use, disposable 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 EU regulations, we will replace all sensors confirmed to have failed within their intended lifetime following our investigation.
1. CONDITIONS OF NON-REPLACEMENT
1.1 GlucoSensor™ will not replace sensors that detach from the placement site due 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. reserves the right to assess each case individually. In such cases, MicroTech Medical Inc., as the manufacturer of the CGM system, is not responsible for adhesive-related issues or any sensor performance concerns related to improper placement or 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 page 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 by our Technical Support leadership team on a case-by-case basis. DiaX Medical reserves the right to modify these thresholds at its discretion. Users should be aware that these replacement sensors are provided at DiaX Medical’s sole discretion and do not establish a binding precedent or obligation to offer further replacements.
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.
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 by email in accordance with the provisions of the Website EULA.
5.2 Case-by-case review:
All requests for replacements that do not fall under this policy will be reviewed on a case-by-case basis, in line with the terms and conditions set forth in 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 at its discretion, ensuring compliance with applicable EU consumer protection laws.
6. INTEGRATION WITH OTHER TERMS
6.1 Part of the total agreement:
This Sensor Replacement Policy forms part of the overall Terms of Use for the GlucoSensor™ services, which include the Website End-User License Agreement (Website EULA), App End-User License Agreement (App EULA), General Delivery Conditions, Privacy Policy, and Returns and Refund Policy. Users should consult the EULAs for a complete understanding of the terms that govern their use of our products and services, including limitations on liability, warranties, and dispute resolution procedures.
7. LIMITATIONS OF DATA ACCURACY DUE TO EXTERNAL FACTORS
The GlucoSensor™ CGM system, developed by MicroTech Medical Inc., may experience sensor performance affected by various external factors, including sensor placement, skin conditions, hydration levels, body temperature, or user activity. If inaccurate readings occur due to these external factors, users must confirm glucose levels using fingerstick tests or other traditional methods before making treatment decisions. DiaX Medical B.V. and MicroTech Medical Inc. disclaim responsibility for inaccurate readings caused by such external conditions or user handling errors.
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