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Medtronic MiniMed 530G Manual

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During the conduct of the Performance Evaluation of the Enlite™ Glucose Sensor
to Support a Full 144 Hours (6 Days) of Use1, the following specic sensor risks
were identied:
• Pain at sensor insertion site during sensor wear (1 incident reported)
• Dermatological risks (number of events/number of skin assessments
performed):
• Redness due to device insertion (abdomen, 35/213)
• Redness in area of adhesive (abdomen, 63/213)
• Bruising (abdomen, 2/213)
• Bump (induration) (abdomen, 1/213)
• Bleeding:
– Bleeding immediately after insertion (abdomen, 2/213)
– Bleeding at removal (abdomen, 5/213)
• Fluid discharge (abdomen, 1/213)
• Other, including indentation from device, e.g., transmitter (abdomen,
9/213)
Taking medications with acetaminophen while wearing the sensor may falsely raise
your sensor glucose readings. The level of inaccuracy depends on the amount of
acetaminophen active in your body and may be dierent for each person. Always
use BG meter readings to verify your glucose level before making therapy
decisions.
The Enlite Sensor is not approved for use in children or adolescents aged younger
than 16 years, pregnant women, or persons on dialysis.
It is not known how dierent conditions or medications common to the critically
ill population may aect the performance of the system. Therefore, the use of this
sensor in the critically ill population is not recommended.
Sensor placement and insertion is not approved for sites other than the belly
(abdomen).
1 Medtronic Inc., A Performance Evaluation of the Enlite™ Glucose Sensor to Support a Full 144 Hours
(6 Days) of Use, CER247/Z25/C, May 2012.
■ introduction
Introduction 11
… 29 …


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