Guardian 4 - Risks and Side Effects; Reagents; Removing the Sensor

- 4 -
Risks and side effects
Risks related to sensor use include
• Skin irritation or other reactions
• Bruising
• Discomfort
• Redness
• Bleeding
• Pain
• Rash
• Infection
• Raised bump
• Appearance of a small “freckle-like” dot where the sensor was
inserted
• Allergic reaction
• Fainting secondary to anxiety or fear of needle insertion
• Soreness or tenderness
• Swelling at insertion site
• Sensor fracture, breakage or damage
• Minimal blood splatter associated with sensor needle removal
• Residual redness associated with adhesive or tapes or both
• Scarring
Reagents
The Guardian 4 sensor contains two biological reagents: glucose
oxidase, and human serum albumin (HSA). Glucose oxidase is
derived from Aspergillus niger and manufactured to meet industry
requirements for the extraction and purification of enzymes for use
in diagnostic, immunodiagnostic, and biotechnical applications.
The HSA used on the sensor consists of purified and dried albumin
fraction V derived from pasteurized human serum, which is cross-
linked via glutaraldehyde. Approximately 3 μg of glucose oxidase
and approximately 10 μg of HSA are used to manufacture each
sensor. HSA is approved for IV infusion in humans at quantities
much larger than in the sensor.
Removing the sensor
To change the Guardian 4 sensor, disconnect the transmitter from
the sensor as described in the Guardian 4 transmitter user guide.
Gently pull the sensor from the body to remove it. Discard the
sensor in a sharps container.