Automatic Self-Test; Control Test - McKesson TRUEresult Owner's Manual

TRUEresult Quality Assurance / Quality Control Manual
®
Quality Control Testing
Quality Control procedures are used to detect errors that may occur due to test system
errors, product defects, adverse environmental conditions and variance in operator
performance. Ongoing QC procedures are also used to detect any performance issues of
the System over time. Facility Quality Control Testing Policy and Procedure should
adhere to the manufacturer's instructions for use and regulatory guidelines set forth by
appropriate state, regional or national licensing or accrediting agencies.
TRUEresult is a no-coding system, which means the Meter does not have to be coded to
each lot of Test Strips. To assure accurate and reliable results, TRUEresult offers two
kinds of Quality Control Tests. These tests ensure that TRUEresult is working properly
and testing technique is good.

Automatic Self-Test

An automatic self-test is performed by the Meter each time a TRUEtest Strip is inserted
correctly into the Test Port. After inserting the Strip into the Test Port, if the full Display
(showing no missing segments, see Description of System, Section 2) followed by the
Drop Symbol appears, the Meter is working properly. If an error message (E-1, E-2 etc.)
appears in the Display after inserting a Test Strip, the Meter will not perform a glucose
test. See Display Messages, Section 8 for more information on error messages.
CAUTION! If any segments are missing in the Display when the Test Strip is inserted
into the Test Port, do not use the Meter for testing. Call for assistance
using the phone number on the QA/QC Manual cover.

Control Test

Use ONLY TRUEtest Glucose Control Solution to check the performance of the System.
It is important to perform Control Tests with more than one level of Control to assure that
the System is working properly and testing technique is good. Three levels of TRUEtest
Glucose Control Solution (Levels 1-3) containing known amounts of glucose are
available. Call the phone number on the QA/QC Manual cover or contact your supplier
to order different levels of Control Solution. Control Test(s) should be performed:
• Before using the System for the first time,
• For practice to ensure that testing technique is good,
• When opening a new vial of Strips,
• If results seem unusually high or low based on the patient's condition,
• If Strip vial has been left open or exposed to extreme heat, cold or humidity,
• Whenever a check on the performance of the System is needed, or
• If Meter damage is suspected (Meter dropped, crushed, wet, etc.).
CAUTION! Glucose Control ranges printed on the Test Strip vial are ranges for
Control Tests results only. These ranges are not to be used by patients
for blood glucose management. Contact a Doctor or Diabetes Healthcare
Professional for individualized blood glucose target ranges. DO NOT
consume Glucose Control.
Drop Symbol
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