ATELLICA IM VITAMIN B12 (VB12)

Description of Event or Problem

THE CUSTOMER REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING REAGENT LOT# 299. AN INITIAL ELEVATED VB12 RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER AND OBTAINED A LOWER RESULT, WHICH WAS CONSIDERED CORRECT AND ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

Additional Manufacturer Narrative

AN OUTSIDE OF UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS REMOTE SERVICES CENTER (RSC) AND REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS EVALUATED THE INSTRUMENT, CALIBRATION, AND QUALITY CONTROL (QC) DATA PROVIDED BY THE CUSTOMER. QC RESULTS WERE OUT-OF-RANGE ON THE EVENT DATE FOLLOWING PATIENT SAMPLE PROCESSING, ALTHOUGH CALIBRATION REMAINED VALID. SIEMENS WAS UNABLE TO VERIFY THE PERFORMANCE OF THE VB12 REAGENT PACKS DUE TO THE CONCURRENT USE OF MULTIPLE PRIMARY AND ANCILLARY REAGENT PACKS DURING THEIR ONBOARD STABILITY PERIOD. DISCORDANT RESULTS WERE OBSERVED IN ONLY A FEW SAMPLES; HOWEVER, MULTIPLE OTHER PATIENT SAMPLES TESTED BEFORE AND AFTER, USING THE SAME REAGENT AND ANCILLARY PACKS, PRODUCED CONSISTENT RESULTS WITHOUT SYSTEM ERRORS. THE CUSTOMER REPLACED BOTH THE PRIMARY AND ANCILLARY REAGENT PACKS IN QUESTION WITH ALTERNATIVE VB12 REAGENT AND ANCILLARY PACKS, AND NO FURTHER ISSUES WERE REPORTED. SIEMENS FURTHER EVALUATED THE EVENT AND DETERMINED THAT DISCORDANT RESULTS MAY OCCUR DUE TO IMPROPER MIXING, DELAYS BEFORE USE, OR INCORRECT VOLUMES DURING MANUAL PREPARATION OF THE DTT REAGENT. THE USER WAS RECOMMENDED TO REVIEW THE PROPER PREPARATION AND HANDLING PROCEDURES FOR THE DTT/RELEASING AGENT AS OUTLINED IN THE ATELLICA IM VB12 INSTRUCTIONS FOR USE (IFU), UNDER THE SECTION "PREPARING THE REAGENTS." 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 WAS UNABLE TO BE DETERMINED. NO PRODUCT PROBLEM HAS BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING.