The GEM Premier 4000 analyzer incorporates Intelligent Quality Management (iQM) as an automated Quality Assurance system that replaces the use of External Quality Controls (EQC). The iQM operations can be summarized as follows:
- Monitors the performance of the system in real-time.
- Identifies the potential failure patterns.
- Automatically performs corrective actions.
- Automatically documents the failure and corrective action taken.
Upon insertion of a cartridge into the analyzer, The GEM Premier 4000 system reads and records all factory-assigned cartridge information. External GEM CVP Solution must be manually run by the operator to complete the internal calibration process and final accuracy assessment. Calibration Valuation Product (CVP) is intended for the verification of the integrity of the new cartridge every time it is replaced. All levels of CVP must pass for each analyte before the instrument can be used for patient testing. CVP material has lot-specific information which must be verified by the user when Quality Control (QC) is run.
GEM 4000 Maintenance Issues and QC Log