Replacement Policy

This policy governs sensor replacement claims for the Sibionics GS1 Continuous Glucose Monitoring (CGM) System sold and serviced through BF Biosciences' authorized channel in Pakistan. It is aligned to the sensor's 14-day service life, in line with Sibionics' own global after-sales terms: a device is only warranted for quality-related failures occurring within that 14-day window — claims made after day 14 are not honoured, as the sensor has reached the end of its intended service life regardless of the issue.

Eligible for Replacement

All of the following conditions must be met for a claim to qualify:

1. The sensor was applied correctly, per manufacturer instructions.
2. The sensor initially activated and recorded readings on the app — confirming correct application — then stopped working, gave inaccurate data, or malfunctioned before completing its 14-day service life.
3. Installation was carried out by, or under, a BF Biosciences authorized representative via the home delivery & installation service.
4. The issue was reported to our team within 24–48 hours of occurrence.
5. Supporting proof was submitted as per Section 4.

Excluded from Replacement

3.1 Installation & Handling

• Self-installed devices that fail immediately after application, or are damaged during self-installation — not covered unless our representative performed the install.
• Sensor detachment caused by impact, knocks, or movement (e.g. sleeve caught on an object, bumped against a surface, pulled off) where the sensor had worked and recorded initial data. This is treated as physical/accidental damage rather than a device defect, and is excluded — unless the sensor was properly attached per instructions and stopped working on its own before completing day 14.
• Product tampering — visible removal of the needle/probe/electrode, or signs of interference with the sensor's calibration hole.
• Misuse or improper handling: not following wear/storage guidelines, e.g. submerging beyond 1 metre / 1 hour, exposure to extreme heat or cold, or failure to remove the sensor before MRI, CT, X-ray, or diathermy procedures.

3.2 Product & Sourcing

• Sensor used beyond its 14-day service life, or applied after its printed shelf-life/expiry date.
• Product purchased outside the authorized BF Biosciences channel (grey market, personal import, unauthorized reseller) — mirrors Sibionics' own global policy of denying after-sales support for third-party-sourced units.
• Cosmetic wear only (overpatch discolouration, minor adhesive residue) with no functional impact on readings.
• Connectivity or data issues traced to an unsupported or incompatible phone, rather than a sensor fault.

3.3 Claim Frequency

• Repeat “goodwill” replacements are capped at one per patient per batch/lot, unless a manufacturing defect is confirmed at the lot level.

3.4 Sensor Behaviour Exceptions (Not Faults)

• Overpatch removal or replacement during the 14-day wear period does not itself count as sensor detachment or malfunction — the overpatch is a secondary adhesive layer, separate from the sensor housing.
• No data during the first 60 minutes after application — this is the mandatory sensor warm-up period, not a fault.
• Abnormal readings while skin/ambient temperature is outside 5–40°C — the sensor is only rated within this range and resumes normal operation once back in range.

SIBIONICS

• Falsely elevated readings while the patient is on painkillers, vitamin C, or hydroxyurea — a known interference effect, not a device defect. Confirm via fingerstick comparison before logging as a quality complaint.

4. Required Documentation (per claim)

1. Screenshot of the app showing the error or fault.
2. Photo of the application site (arm) showing how the sensor was worn.
3. Photo of the sensor itself — needle/probe/electrode status, and the small calibration hole (to confirm no tampering).
4. The sensor's LT/AA connection code — one replacement is issued per code.
5. Order ID / proof of purchase through the authorized channel.
6. Installation confirmation — representative name/ID and install date, from the home-installation log.
7. For accuracy complaints: two side-by-side glucose readings (fingerstick vs. sensor) for comparison.

5. Claim Process

1. Patient or pharmacy reports the issue to the assigned representative or helpline within 24–48 hours.
2. Representative collects the documentation in Section 4, on-site or by guiding the patient through it remotely.
3. Claim is reviewed against the eligibility and exclusion criteria in Sections 2 and 3.
4. Decision communicated to the patient within the agreed turnaround time (TAT: ____ working days).
5. Approved claims are replaced via the same home-delivery channel, with re-installation by the representative.

6. Medical Disclaimer

1. The CGM system and its companion app are monitoring aids, not a substitute for professional medical care. Glucose data is not independently verified for clinical accuracy by BF Biosciences or Sibionics; patients experiencing symptoms inconsistent with sensor readings should perform a fingerstick test and consult their healthcare provider rather than relying on the device alone. This mirrors Sibionics' own Terms of Use, which disclaim the Services as a replacement for proper medical care.

7. Open Items for Sign-Off

1. The following require a decision before this policy is finalized and circulated:
   • Turnaround time (TAT) to commit to for a claim decision and replacement.
   • Whether the “installed-by-representative-only” rule applies to every sale, or only where the installation service was purchased — and if patients who self-administer by choice forfeit free replacement entirely, or receive a paid/reduced-cost replacement instead.
   • Whether a confirmed lot-level defect (multiple failures traced to the same batch) should override the “no replacement without representative install” rule, since that points to a manufacturing issue rather than an application error.