ATELLICA IM VITAMIN B12 (VB12)

Description of Event or Problem

THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES WHEN USING REAGENT LOT 300 ON AN ATELLICA IM 1300 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE NOT REPEATED BECAUSE THE SAMPLES WERE DISCARDED BY THE TIME THE PHYSICIAN CALLED THE LAB. THE CUSTOMER CONFIRMED THAT THE PATIENTS WERE NOT REDRAWN. THE CORRECT RESULTS ARE UNKNOWN FOR THESE SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED VB12 RESULTS.

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON AN ATELLICA IM 1300 ANALYZER. QUALITY CONTROL (QC) AND CALIBRATION WERE ACCEPTABLE WHEN THE ERRONEOUS RESULTS WERE OBTAINED. SIEMENS REVIEWED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER AND RULED OUT REAGENT ISSUES BASED ON THE REVIEW OF QC WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. DURING THE VISIT, THE CSE PERFORMED A TOTAL SERVICE VISIT (TSV), AND NO ISSUES WERE FOUND THAT AFFECTED THE ASSAY OR INSTRUMENT'S PERFORMANCE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULTS WAS UNABLE TO BE DETERMINED AS REPEAT TESTING WAS NOT PERFORMED TO VERIFY ASSAY PERFORMANCE. THE ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING; A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND NO FURTHER ACTIONS ARE REQUIRED.