ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

CALIBRATION RESULTS FROM 26-JAN-2023 WERE BELOW THE EXPECTED RANGE FOR BOTH CALIBRATOR LEVELS. QUALITY CONTROL RESULTS WERE WITHIN THE EXPECTED RANGE. THERE IS NO INDICATION FOR A REAGENT ISSUE. THE LAST INSTRUMENT MAINTENANCE WAS PERFORMED AT THE BEGINNING OF JANUARY-2023. THE PATIENT¿S SAMPLE WAS REQUESTED BUT NOT AVAILABLE FOR INVESTIGATION. BOTH ROCHE AND COMPETITOR-GENERATED RESULTS MATCH IN THE RELATION TO THE RESPECTIVE EXPECTED RANGES. THE MEASURED VITAMIN B 12 VALUE OF A PATIENT¿S SAMPLE CAN VARY DEPENDING ON THE TESTING PROCEDURE USED. ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED AND, DIFFERENCES IN REFERENCE MATERIALS/METHODS, AND THE STANDARDIZATION METHODOLOGY USED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

NA.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS VITAMIN B12 II ASSAY ON A COBAS E 411 ANALYZER (SERIAL NUMBER UNKNOWN) AND COMPARED TO A COMPETITOR METHOD. THE SAMPLE INITIALLY RESULTED IN A VITAMIN B 12 II VALUE OF 640 PG/ML ON THE COBAS E 411 ANALYZER. THE REPORTER MENTIONED THAT THIS RESULT WAS REPRODUCIBLE. NO SPECIFIC VALUE WAS PROVIDED. THE SAMPLE WAS REPEATED WITH A COMPETITOR METHOD, RESULTING IN A VITAMIN B 12 VALUE OF 468 PG/ML. IT WAS ASKED BUT IT IS UNKNOWN WHICH RESULT IS CONSIDERED TO BE CORRECT. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.