A SIEMENS TECHNICAL APPLICATION SPECIALIST (TAS) WAS DISPATCHED TO THE CUSTOMER SITE. THE TAS RAN SAMPLE ID (B)(6) ON THE IMMULITE 2000 XPI INSTRUMENT AND ON THE ADVIA CENTAUR INSTRUMENT WITH AND WITHOUT HUMAN ANTI-MOUSE ANTIBODY (HAMA) BLOCKING TUBE, AND ALL RESULTS WERE LOWER INDICATING NO HAMA INTERFERENCE. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE SAMPLE DATA. THE HSC SPECIALIST INDICATED THAT THE IMMULITE 2000 PROGESTERONE ASSAY IS TRACEABLE TO AN INTERNAL STANDARD MANUFACTURED USING QUALIFIED MATERIALS AND MEASUREMENT PROCEDURES. PROGESTERONE METHODS VARY IN STANDARDIZATION ACROSS VENDOR PLATFORMS. NO SAMPLE WAS AVAILABLE FOR IN-HOUSE TESTING. THE CAUSE OF THE DISCORDANT, FALSELY LOW PROGESTERONE RESULTS ON ONE PATIENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.
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Patient 1
THE CUSTOMER OBTAINED A DISCORDANT, FALSELY LOW PROGESTERONE RESULT ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 466. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE SAMPLE WAS SENT TO AN ALTERNATE LABORATORY WHERE IT WAS TESTED ON AN ALTERNATE PLATFORM, RESULTING HIGHER AND MATCHING THE CLINICAL PICTURE OF THE PATIENT. THE CORRECTED RESULT OBTAINED FROM THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE IMMULITE 2000 XPI INSTRUMENT, STILL RESULTING LOWER. THE SAMPLE WAS THEN REPEATED ON THE ADVIA CENTAUR INSTRUMENT, RESULTING HIGHER. THE CUSTOMER ALSO REPORTED THAT THE PREVIOUS SAMPLE (SAMPLE ID (B)(6)) FROM THIS PATIENT WAS ALSO FALSELY LOW, WHEN RUN ON THE IMMULITE 2000 XPI INSTRUMENT, WHILE THE RESULT WAS HIGHER WHEN RUN ON THE ALTERNATE PLATFORM. IT IS UNKNOWN WHICH RESULT WAS REPORTED FOR SAMPLE ID (B)(6).