Adverse Events; Product Specifications; Sensor Product Specifications - Dexcom G5 User Manual

difference (%) from the SMBG values was calculated. The percentages of total readings within 15 mg/
dL or 15%, 20 mg/dL or 20%, 30 mg/dL or 30%, 40 mg/dL or 40% or greater than 40 mg/dL or 40%
were then calculated.
For example, if the system reads 100 mg/dL, it is between 81-180 mg/dL range and you can expect
the system readings to be within 20% of the SMBG values 85% of the time for the
Adult Study, as seen in Table 11-A.
Overall, the system in the
Difference) than SMBG values and 11.3% absolute different (Mean Absolute Percent Difference) than
the SMBG values. The Median Percent Difference shows that half of the time the system reads lower in
2.7% or less than the SMBG values and the Median Absolute Percent Difference shows that half of the
time the system reads about 8.6% or less different than SMBG values, as seen in Table 12-A.

Adverse Events

No serious adverse events or device-related serious adverse events occurred during the studies. Mild
to moderate skin irritation, such as erythema or edema, occurred at the sensor needle insertion area
or around the adhesive area. No infection, bruising, or bleeding occurred at the sensor needle insertion
area or the adhesive area.

18.2 Product Specifications

User is the single use operator in the home environment.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer
of this equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
Do not touch the metal connectors on the bottom of the transmitter and other open connectors on the
receiver, charging cable and charger.

Sensor Product Specifications

Glucose Range
Sensor Useful Life
Calibration
Calibration Range
Storage and Transport
Conditions
Sterilization
Dexcom G5 Mobile System User Guide
Technical Information
Software 505 Adult
Study reads, on average, 2.6% lower (Mean Percent
40-400 mg/dL
Up to 7 days
Commercially available BG meter
40-400 mg/dL
Temperature: 36° F-77° F
Humidity: 15%-85% RH
Sterile by radiation
Software 505
337