THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER FOR THE DISCORDANT, FALSELY ELEVATED LOW VOLUME MASS CREATININE KINASE (LMMB) RESULT ON A DIMENSION EXL INSTRUMENT. SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) HAS COMPLETED THE INVESTIGATION OF THE INCIDENT. HSC EVALUATED THE DATA PROVIDED. NO INSTRUMENT ISSUES HAVE BEEN REPORTED OR IDENTIFIED. LMMB QC WAS WITHIN REFERENCE RANGES ON THE DATE OF THE INCIDENT. THIS EVENT IS LIMITED TO A SPECIFIC PATIENT SAMPLE. THE CAUSE OF THE DISCORDANT ELEVATED LMMB RESULT IS UNKNOWN. PER THE LMMB FLEX REAGENT CARTRIDGE INSTRUCTIONS FOR USE: "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT WITH IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. THIS ASSAY HAS BEEN DESIGNED TO MINIMIZE INTERFERENCE FROM HETEROPHILIC ANTIBODIES. NEVERTHELESS, COMPLETE ELIMINATION OF THIS INTERFERENCE FROM ALL PATIENT SPECIMENS CANNOT BE GUARANTEED. A TEST RESULT THAT IS INCONSISTENT WITH THE CLINICAL PICTURE AND PATIENT HISTORY SHOULD BE INTERPRETED WITH CAUTION." THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
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Patient 1
A DISCORDANT, FALSELY ELEVATED MASS CREATINE KINASE MB ISOENZYME (LMMB) WAS OBTAINED ON A PATIENT SERUM SAMPLE ON THE DIMENSION EXL INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS SENT TO AN ALTERNATE LABORATORY FOR TESTING ON AN ALTERNATE NON-SIEMENS METHODOLOGY AND A LOWER RESULT WAS OBTAINED. A CORRECTED RESULT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED LMMB RESULT.