THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) FOR THE DISCORDANT ELEVATED LIPL RESULT OBTAINED ON THE INITIAL SAMPLE ON THE DIMENSION EXL SYSTEM. SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) HAS REVIEWED THE INSTRUMENT DATA AND COMPLETED THEIR EVALUATION. HSC DOES NOT SUSPECT AN INSTRUMENT OR REAGENT ISSUE AS QC IS VERY CONSISTENT. SYSTEM CHECKS WERE ALL WITHIN RANGE. NO PRODUCT NON-CONFORMANCES WERE IDENTIFIED. THE CAUSE IS UNKNOWN. THE SYSTEM IS OPERATING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
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Patient 1
A DISCORDANT ELEVATED LIPASE (LIPL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL 200 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT HAD A NEW SAMPLE DRAWN AT A LATER TIME ON THE SAME DATE AND A LOWER RESULT WAS OBTAINED AND REPORTED. NO CORRECTED REPORT WAS ISSUED. THE PATIENT WAS ADMITTED BASED ON THE SYMPTOMS AND LABORATORY RESULT OF THE ELEVATED LIPASE FOR EVALUATION AND FLUIDS (SUSPECTED PANCREATITIS). THE PATIENT WAS GIVEN NACL IV FLUIDS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED LIPL RESULT OR TREATMENT.