ATELLICA IM VITAMIN B12 (VB12)

Description of Event or Problem

THE CUSTOMER REPORTS AN OBSERVATION OF ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULTS ON TWO PATIENT SAMPLES ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER PERFORMED REPEAT TESTING OF THE PATIENT SAMPLES AFTER FAILING IN THE MOVING AVERAGES. THE SAME SAMPLES WERE REPEATED ON ALTERNATE ATELLICA IM 1600 ANALYZERS. THE LOWER REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULTS.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE OF THE UNITED STATES (OUS) REPORTED AN OBSERVATION OF ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULTS ON TWO PATIENT SAMPLES ON AN ATELLICA IM 1600 ANALYZER. CALIBRATION AND QUALITY CONTROL (QC) RECOVERED WITHIN THE ACCEPTABLE RANGES ON THE DAY OF TESTING, AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. SIEMENS EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE INSTRUMENT DATA FILES AND FOUND THAT MULTIPLE PACKS OF REAGENT AND ANCILLARY REAGENT WERE IN USE ON THIS ATELLICA IM 1600 ANALYZER DURING THE PATIENT TESTING, DUE TO MULTIPLE REAGENT AND ANCILLARY PACKS IN USE AT THE TIME OF THE EVENT, SIEMENS IS UNABLE TO VERIFY PERFORMANCE OF VB12 REAGENT PACKS DURING THE ONBOARD STABILITY OF THE REAGENT. MULTIPLE PATIENT SAMPLES WERE RUN BEFORE AND AFTER THE SAMPLES IN QUESTION ON THE SAME REAGENT AND ANCILLARY PACKS WITHOUT ANY SYSTEM ERRORS OR DISCORDANT RESULTS. THE CUSTOMER RESOLVED THE ISSUE BY REMOVING ANCILLARY PACK AND PRIMARY REAGENT ON ATELLICA IM 1600 ANALYZER AND MOVING ONTO AN ALTERNATE READY PACK AND ANCILLARY PACK OF VB12 REAGENT THAT PRODUCED ACCEPTABLE RESULTS. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE THE DISCORDANT RESULT WAS NOT REPRODUCIBLE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT CANNOT BE DETERMINED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING.