Product Info
Table Of Contents
- M998590A011DOC_A_FINAL_UserGuide_Part2
- Troubleshooting
- Maintenance
- Product specifications and safety information
- Product specifications
- Alarm and alert escalation
- Altitude range
- Audio frequency
- Backlight
- Basal delivery
- BG Target
- BG meter value
- Bolus delivery
- Bolus Wizard feature default settings
- Bolus Wizard feature specifications
- Carb ratios
- Delivery accuracy
- Easy Bolus feature
- Environmental conditions
- Essential performance
- Filling the infusion set and cannula
- Infusion pressure
- Insulin delivery default settings
- Bolus settings
- Basal settings
- Insulin sensitivity factor
- Low Reservoir reminder
- Max Bolus
- Normal bolus
- Occlusion detection
- Percent temp basal
- Program safety checks
- Pump dimensions
- Pump memory
- Pump weight
- Sensor default settings
- Wireless communication
- FCC notice
- IEC60601-1-2:4th Edition notice
- Guidance and manufacturer's declaration
- Icon glossary
- Product specifications
- 670G Performance Data and Technical Information
The Missed Detection Rate is the rate that the device did not alert when it should
have. For example, the blood glucose was below the hypoglycemic threshold, or
above the hyperglycemic threshold, and the device did not sound a threshold or
predictive alert.
Missed detection rates are important because it is necessary that users be notified
when their blood glucose is low (or high), so that they can correct the low (or
high) blood glucose. A low missed detection rate indicates that users can have
confidence that they will be notified by the device if their blood glucose is low or
high.
For example, per the following table, when wearing the sensor in the buttocks, the
threshold alert, predictive alert, or both alert (threshold and predictive) did not
sound 50.0%, 50.0% or 50.0% of the time within 30 minutes (or 50.0%, 50.0% or
50.0% within 15 minutes) when the user had blood glucose less than 60 mg/dL.
Table I-4. Glucose Missed Detection Alert Performance using Calibration every 12 hours
Glucose Missed Detection Rate
mg/dL Insertion Site Threshold Only Predictive Only Threshold & Predictive
30 min 15 min 30 min 15 min 30 min 15 min
50 Abdomen N/A* N/A* N/A* N/A* N/A* N/A*
Buttock N/A* N/A* N/A* N/A* N/A* N/A*
60 Abdomen N/A* N/A* 100.0% 100.0% 100.0% 100.0%
Buttock 50.0% 50.0% 50.0% 50.0% 50.0% 50.0%
70 Abdomen N/A* N/A* N/A* N/A* N/A* N/A*
Buttock 33.3% 33.3% 33.3% 33.3% 33.3% 33.3%
80 Abdomen 0.0% 0.0% 0.0% 100.0% 0.0% 0.0%
Buttock 60.0% 60.0% 40.0% 60.0% 40.0% 60.0%
90 Abdomen 33.3% 33.3% 0.0% 33.3% 0.0% 0.0%
Buttock 20.0% 20.0% 10.0% 40.0% 10.0% 20.0%
180 Abdomen 15.4% 15.4% 7.7% 15.4% 7.7% 15.4%
Buttock 0.0% 1.7% 0.0% 8.6% 0.0% 0.0%
220 Abdomen 0.0% 0.0% 0.0% 12.5% 0.0% 0.0%
Buttock 8.3% 13.9% 2.8% 13.9% 0.0% 5.6%
250 Abdomen 0.0% 0.0% 0.0% 12.5% 0.0% 0.0%
Buttock 16.0% 16.0% 4.0% 16.0% 4.0% 12.0%
300 Abdomen 0.0% 0.0% 0.0% 25.0% 0.0% 0.0%
Buttock 37.5% 37.5% 0.0% 12.5% 0.0% 0.0%
Note: Given the small sample size of data available in the low range, the alert performance in the 50 mg/dL and 60 mg/dL should be interpreted
with caution and may not reflect actual use performance.
*There is no evaluable events in this reference range so it is N/A.
398 Chapter 17