Freestyle Libre 2 Manual Del Usuario página 153

"well-defined redness", and 4 "slight pink"), 5 instances of edema (3 slight edema, 2 slight edema with
defined edges), 2 instances of mild bleeding, one instance of mild induration and one instance of mild
rash.
Ascorbic Acid Interference
Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose
readings. Taking more than 500 mg of ascorbic acid per day may a!ect the Sensor readings which could
cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements including
multivitamins. Some supplements, including cold remedies such as Airborne
contain high doses of 1000 mg of ascorbic acid and should not be taken while using the Sensor. See
your health care professional to understand how long ascorbic acid is active in your body.
Additional notes for Health Care Professionals
A clinical study was conducted to evaluate the e!ect of ascorbic acid on Sensor performance. Data from
57 adult subjects with diabetes was collected over a 13-hour period. Each subject had a one-hour
baseline phase where venous blood was collected every 10 minutes. After this first hour, a dose of
1000 mg ascorbic acid was given with a meal and venous samples were collected every 20 minutes for
the next four hours. A maximum average sensor bias of 9.3 mg/dL was observed around 3 hours after
the 1000 mg ascorbic acid dose. Subjects then received a second dose of 1000 mg ascorbic acid with a
meal and the same process was continued for another 4 hours. A third dose of 1000 mg ascorbic acid
was then given and study subjects were followed for 4 more hours. After the second dose of ascorbic
acid the maximum average sensor bias increased, with minimal change in sensor bias after the third
dose, suggesting that saturation had occurred by the second 1000 mg dose of ascorbic acid. The
maximum average sensor bias after the three 1000 mg doses of ascorbic acid was less than 20 mg/dL.
Electromagnetic Compatibility (EMC)
FreeStyle Libre 2 Reader - FCC ID: QXS-LIB02
FreeStyle Libre 2 Sensor - FCC ID: QXS-LIB02S
FreeStyle Libre 2 MediRx Sensor - FCC ID: QXS-LIB02S
The System needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual.
Portable and mobile RF communications equipment can a!ect the System.
Use of accessories, transducers, and cables other than those specified or provided by Abbott
Diabetes Care could result in increased electromagnetic emissions or decreased electromagnetic
immunity of the System and result in improper operation.
The System should not be used adjacent to or stacked with other equipment and that if adjacent or
stacked use is necessary, the System should be observed to verify normal operation in the
configuration in which it will be used.
The device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) The device may not cause harmful interference, and (2) the device must accept any
interference received, including interference that may cause undesired operation.
ART46983-001_rev-A 24-Aug-2022 2:30pm
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