IMMULITE 2000

Description of Event or Problem

A DISCORDANT, FALSELY LOW PROGESTERONE RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR VALIDATION ON THE SAME INSTRUMENT, RESULTING HIGHER. THE SAMPLE WAS THEN REPEATED AGAIN ON THE SAME INSTRUMENT, RESULTING SIMILARLY TO THE PREVIOUS REPEAT RESULT. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PROGESTERONE RESULT.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED TO CCC THAT THE SAMPLE APPEARED SLIGHTLY HEMOLYZED AND THAT QUALITY CONTROLS WERE WITHIN RANGE AT THE TIME OF EVENT. IT WAS DISCOVERED THAT THE CUSTOMER WAS CENTRIFUGING PATIENT SAMPLES OUTSIDE OF THE TUBE MANUFACTURER SPECIFICATIONS. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED THE REAGENT DUAL RESOLUTION DILUTER DUE TO A CRACKED LOWER PISTON AND THE DILUTION WELL DUE TO A NOISY BEARING. THE CSE DECONTAMINATED THE FLUIDIC AND SUBSTRATE SYSTEMS. QUALITY CONTROLS AND A WATER TEST WERE RUN, ALL OF WHICH PASSED. THE CAUSE OF THE DISCORDANT, FALSELY LOW PROGESTERONE RESULT IS UNKNOWN. THE CAUSE OF THE SAMPLES BEING CENTRIFUGED OUTSIDE OF TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.