ATELLICA IM VITAMIN B12 (VB12)

Additional Manufacturer Narrative

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER OBSERVED A DISCORDANCE WITH AN ATELLICA IM VITAMIN B12 (VB12), LOT 298 PATIENT RESULT, WHERE THE INITIAL RESULT WAS WITHIN THE ASSAY REFERENCE RANGE, BUT THE RETEST WAS BELOW THE ASSAY REFERENCE RANGE. THE LOWER RESULT WAS CONSIDERED CORRECT. SIEMENS INVESTIGATED THE EVENT. BASED ON THE COMPLAINT INFORMATION, THE CUSTOMER RETESTED PATIENT SAMPLES AFTER THEY IDENTIFIED A MOVING AVERAGE VIOLATION FOR VB12 QUALITY CONTROL (QC) ON ATELLICA IM SERIAL NUMBER (B)(6). THE PATIENT SAMPLES WERE INITIALLY RUN ON (B)(6) 2025 AND WERE RETESTED SEVERAL HOURS LATER ON THE SAME DAY ON AN ALTERNATE ATELLICA IM WITHIN THE LAB. UPON RETEST OF PATIENT SAMPLE, VB12 RESULTS WERE DECREASED. SIEMENS REVIEWED VB12 QUALITY CONTROL (QC) DATA AND FOUND IT WAS IN RANGE ON VB12 REAGENT AND ANCILLARY PACK COMBINATIONS THAT INCLUDED THE RETESTED PATIENT RESULTS, INCLUDING THE SAMPLE IN QUESTION. THE VB12 CALIBRATIONS USED DURING PATIENT TESTING SHOWED ACCEPTABLE PERFORMANCE. MULTIPLE PATIENT SAMPLES WERE RUN BEFORE AND AFTER THE EVENT ON THE SAME REAGENT AND ANCILLARY PACKS WITHOUT SYSTEM ERROR OR OTHER DISCORDANT RESULTS. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE DISCORDANT RESULT WAS NOT REPRODUCIBLE. THE ANALYSIS OF THE PATIENT DATA INDICATES A POTENTIAL ISSUE WITH SPECIMEN INTEGRITY OR QUALITY AT THE CUSTOMER SITE. THE PRESENCE OF CELLULAR DEBRIS, LIKELY DUE TO IMPROPER SPECIMEN HANDLING, IS A PLAUSIBLE FACTOR CONTRIBUTING TO THE PATIENT'S INITIALLY ELEVATED VITAMIN B12 (VB12) LEVELS, WHICH NORMALIZED UPON RETESTING WITH DILUTION AND/OR SERUM SETTLING BETWEEN SAMPLE TESTING TIMES. THE VB12 INSTRUCTIONS FOR USE (IFU) SPECIMEN COLLECTION AND HANDLING SECTIONS RECOMMEND THAT CUSTOMERS FOLLOW THE INSTRUCTIONS PROVIDED WITH THEIR SPECIMEN COLLECTION TUBE MANUFACTURER. FAILURE TO OBSERVE THE TUBE MANUFACTURER¿S RECOMMENDATIONS FOR SPECIMEN COLLECTION AND HANDLING MAY RESULT IN COMPROMISED PATIENT RESULTS, INCREASED TURNAROUND TIMES AND ADDED OR EXCESSIVE MAINTENANCE TO THE ANALYZER. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS CONSISTENT WITH A SAMPLE SPECIFIC INTEGRITY ISSUE. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE IS RESOLVED BY ROUTINE TROUBLESHOOTING.

Description of Event or Problem

THE CUSTOMER OBTAINED A DISCORDANT (ELEVATED) ATELLICA IM VITAMIN B12 (VB12), LOT 298 RESULT ON A PATIENT SAMPLE. THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE CUSTOMER DISCOVERED OUT OF RANGE QUALITY CONTROL (QC) RESULTS AND RETESTED THE SAMPLE ON A DIFFERENT ATELLICA IM ANALYZER. THE RETEST RESULT WAS LOWER AND PROVIDED TO THE PHYSICIAN IN A CORRECTED REPORT. THERE ARE NO ALLEGATIONS OF DELAYS, PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.