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Taking medications with paracetamol, including, but not limited to fever reducers
or cold medicine, while wearing the sensor may falsely raise your sensor glucose
readings. The level of inaccuracy depends on the amount of paracetamol active in
your body and may be different for each person. Always use BG meter readings to
verify your glucose level before making therapy decisions, including when you
could have paracetamol active in your body. Always check the label of any
medications to confirm whether paracetamol is an active ingredient.
Sensor placement and insertion has been studied in the belly (abdomen) and
upper arm only and is not approved for other sites.
Risks related to serter use
General risks with serter use may include skin infection around the area where the
serter is used.
Risks related to the MiniMed 640G insulin pump system
General risks related to the MiniMed 640G insulin pump system may include:
•Hypoglycemia
Hyperglycemia
Specific risks related to the MiniMed 640G insulin pump system
During the conduct of the In-Clinic, Randomized, Cross-Over Study to Assess the
Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm X54
System with Hypoglycemic Induction from Exercise 1, the following specific system
risks were identified:
Bruising at sensor site (1 incident reported)
Bleeding at sensor site (1 incident reported)
Urine ketones resulting from improper connection of the tubing to the insulin
pump (1 incident reported)
1 Medtronic Inc., An In-Clinic, Randomized, Cross-Over Study to Assess the Efficacy of the Low Glucose
Suspend (LGS) Feature in the MiniMed Paradigm X54 System with Hypoglycemic Induction from
Exercise, CER235/Z25/A, November 2011.
8Chapter 1
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