Control Testing and Quality Control
142
Manufacturer recommended frequency of quality control tests:
*only on days when the cobas h 232 meter is used for measurements
Manufacturer recommended use:
QC recommendations by national associations or local hospital guidelines take precedence over
manufacturer recommendations
WARNING
Potential risk of incorrect patient results
Failure to check the system regularly by performing quality control tests
may lead to incorrect results and therefore to inappropriate therapy deci-
sions. To ensure that the system is functioning properly adhere to the
manufacturer recommendations on quality control testing given in the
tables below.
Frequency Material to test Reason Release criteria
Daily* CARDIAC IQC High
and
CARDIAC IQC Low
Verification of the proper
functioning of the optical
system
Both levels are “Pass”
Frequency Material to test Reason Release criteria
Once a month
Roche CARDIAC Controls
To verify adequate
storage at customer site
Results are within the
range provided by the
manufacturer
With each new shipment
of test strips
To verify proper function-
ing after transportation to
customer site
When an implausible
result is obtained
When an operator uses
the cobas h 232 system
(meter with or without
scanner) for the first time
To qualify the new
operator; to verify proper
handling and sample
dosing
After adverse events such
as dropping the meter or
other strong mechanical
shocks.
Roche CARDIAC Controls
and
CARDIAC IQC High
and
CARDIAC IQC Low
To verify proper function-
ing of the meter
Results are within the
range provided by the
manufacturer
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