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Patient 1
THE OPERATOR OF THE IMMULITE INSTRUMENT CALLED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT A THYROID STIMULATING HORMONE (RAPID TSH) DISCORDANT LOW PATIENT RESULT. THE CCC SPECIALIST INQUIRED ABOUT THE INSTRUMENT PERFORMANCE AND WAS INFORMED THAT ALL MAINTENANCE WAS UP TO DATE. THE OPERATOR CONFIRMED ALL REAGENTS WERE HANDLED IN ACCORDANCE WITH PACKAGE INSERT DIRECTIONS, ALL QUALITY CONTROLS (QC) ARE RESULTING IN RANGE, AND THERE WERE NO ERRORS POSTED AT THE TIME OF TESTING. SINCE THE OPERATOR COULD NOT PERFORM ANY ADDITIONAL TROUBLESHOOTING, THE OPERATOR CALLED BACK AND INFORMED THE CCC THAT REPEAT TESTING WAS PERFORMED TO CONFIRM THE CORRECT PATIENT RESULT. IN ADDITION, THE OPERATOR ALSO CLARIFIED THAT THE AFFECTED SAMPLE WAS FROZEN AND THAWED BETWEEN EACH REPEAT TESTING. THE CCC THEN PROVIDED INSTRUCTIONS TO RUN SEVERAL DIAGNOSTICS TESTS TO ENSURE NO MECHANICAL OR FLUIDIC ISSUES. AFTER THE ALL INSTRUCTIONS WERE PERFORMED, THE OPERATOR CONFIRMED NO AIR OR LEAKS IN FLUIDICS, SYRINGES OPERATE AS NORMAL, PIPETTOR LEVEL SENSING IS OPERATIONAL, AND NO ISSUES WITH THE SUBSTRATE DISPENSE OR WASH SPINNER SPEED. THE CAUSE OF THE DISCORDANT, FALSELY LOW RAPID TSH RESULT ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO THE SPECIFICATIONS AND NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE INSTRUMENT WAS MANUFACTURED BEFORE SEPTEMBER 2016, AND UDI NUMBER IS NOT AVAILABLE.