ATELLICA IM VITAMIN B12 (VB12)

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHILE USING LOT 296. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS TESTED WHILE QUALITY CONTROL (QC) WAS OUT OF RANGE. AS A RESULT, THE SAME SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER AFTER QC RECOVERED WITHIN LABORATORY ESTABLISHED RANGES AND OBTAINED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT AND ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

Additional Manufacturer Narrative

A CUSTOMER FROM THE UNITED STATES REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED INVESTIGATION OF THE EVENT. SIEMENS REVIEW OF ASSAY QUALITY CONTROL (QC) DATA SHOWED OUT OF RANGE RESULTS BEFORE AND AFTER PATIENT TESTING. THE QC ISSUE WAS RESOLVED BY PERFORMING RECALIBRATION OF THE ASSAY. RETURN OF THE PATIENT SAMPLE FOR INVESTIGATION IS NOT WARRANTED, AS THE DISCORDANT RESULTS WERE NOT REPRODUCIBLE. BASED ON THE AVAILABLE INFORMATION, A SPECIFIC CAUSE FOR THE DISCORDANT RESULTS WAS UNABLE TO BE DETERMINED. A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. THE CUSTOMER IS OPERATIONAL, AND THERE ARE NO RESIDUAL ISSUES.