THREE PATIENT SAMPLES RESULTED FALSELY LOW AND ONE PATIENT SAMPLE RESULTED WITH SLASH-MARKS (/////) FOR DIGOXIN ON AN ADVIA 1800 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). WHEN THE OPERATOR RERAN QUALITY CONTROLS (QC) FOR DIGOXIN AS SCHEDULED, THE QC WAS OUT OF RANGE. THE OPERATOR RECALIBRATED THE INSTRUMENT AND RERAN QC, WHICH WAS WITHIN RANGE. PATIENT SAMPLES TESTED PRIOR TO THE RECALIBRATION WERE THEN RUN, AND THE FOUR SAMPLES WERE DISCORDANT. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DIGOXIN RESULTS.
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Patient 1
A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED A LEAK IN REAGENT PROBE 2 AND THE DIP PUMP. THE FSE REPLACED THE 5 MM SEAL AND THE 1 MM SEAL TO ADDRESS THE LEAKS. THE SYSTEM WAS RECALIBRATED AND QC WAS RUN, ALL OF WHICH WERE WITHIN RANGE. PATIENT SAMPLES WERE RUN AND RESULTED AS EXPECTED. THE CAUSE OF THE DISCORDANT DIGOXIN RESULTS WAS DUE TO THE OUT-OF-RANGE QC. THE CAUSE OF THE QC BEING OUT-OF-RANGE IS UNKNOWN, AS QC CAME INTO RANGE AND PATIENT SAMPLES RESULTED AS EXPECTED ON THE SAME INSTRUMENT PRIOR TO THE SERVICE VISIT. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.