Art: 721317-00D Rev. Date: 13-Aug-12
2
MANUFACTURER’S QUALITY SYSTEM INSTRUCTIONS (CONTINUED)
The list below defines the i‑STAT System MQSI components.
Number MQSI Description
4 Ensure Proper Cartridge Storage
A. Ensure that refrigerator storage conditions for stored cartridges are between
2˚C – 8˚C (35˚F – 46˚F).
B. Ensure that cartridges are not exposed to temperatures exceeding 30˚C (86˚F).
C. Ensure that cartridges are not used after the expiration date printed on the individual
package and box.
D. Ensure that cartridges are not outside the refrigerator for longer than the time frame
indicated on the cartridge box.
E. Ensure that a cartridge is used immediately after it is removed from its package.
F. Ensure that a cartridge taken from refrigerated storage is allowed to stand in its
package at room temperature for 5 minutes before use, or that a box of cartridges
stands at room temperature for one hour before use.
5 Ensure Thermal Probe Check is Performed
Ensure the thermal probe check is performed every 6 months on each handheld reader.
This check can be performed in conjunction with the analyzer software updates.
6 Train Staff on Avoidance of Pre- and Post-analytical Errors
Ensure that users are trained to avoid pre‑analytical errors such as those associated with
sample collection, delays in testing, inadequate sample mixing, and post‑analytical errors
(results reporting and communication).
7 Update Software then Check with External Simulator
Update the i‑STAT System software as provided by Abbott Point of Care (APOC). Check the
handheld with the external Electrical Simulator after software updates.
The thermal probe reading can also be taken from this check.
ADDITIONAL FDA REQUIRED ACTIVITIES FOR i-STAT WAIVED TESTS
For the i‑STAT waived test cartridges, in addition to the MQSI above, the activities listed below must be
conducted. These activities were required by the Food and Drug Administration (FDA) in order for APOC to
obtain waived status for the cartridges.
Number Activity Description
8
Test Liquid Control for a New Shipment of Cartridges
Check one cartridge from each newly received lot with the appropriate i‑STAT control.
• CHEM8+ Cartridges: use CHEM8+ or TriControls Level 1 Control,
• 6+ or Crea Cartridges: use i-STAT or TriControls Level 1 Control,
• E3+, EC4+ or G Cartridges: use i-STAT or TriControls Level 3 Control.
9 Ensure Proper Cartridge Storage (Including Monthly Check)
Verify that cartridges stored at room temperature are within expiration date and that cartridges
have been out of the refrigerator less than the time frame indicated on the cartridge box. If the
temperature at which cartridges are stored is in doubt, use a liquid control to verify that the
cartridges are performing properly.
Check storage conditions monthly by testing one cartridge from refrigerated storage with the
appropriate i‑STAT level control. Select the one cartridge to be tested using the following
order: CHEM8+, 6+, Crea, EC4+, G, E3+. If the cartridge being tested is a:
• CHEM8+ Cartridges: use CHEM8+ or TriControls Level 1 control
• 6+ or Crea Cartridges: use i-STAT or TriControls Level 1 control
• E3+, EC4+ or G Cartridges: use i-STAT or TriControls Level 3 control
• Test the cartridge on any handheld
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