ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) REPLACED THE DEFECTIVE MEASURING CELL. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE. THE INVESTIGATION DETERMINED THAT THE EVENT WAS CAUSED BY THE DEFECTIVE MEASURING CELL.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS VITAMIN B12 II (VITAMIN B12 II) RESULTS FROM FOUR PATIENT SAMPLES TESTED ON THE COBAS E411 DISK. THE REPORTER WAS ABLE TO PROVIDE THREE EXAMPLES OF DISCREPANT RESULTS: ON (B)(6) 2023: THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER DEEMED THE INITIAL RESULTS TOO LOW WHICH PROMPTED THE RERUN OF THE PATIENT SAMPLES. SAMPLE 1 THE INITIAL RESULT WAS 130.2 PG/ML. THE REPEAT RESULT WAS 214.9 PG/ML. SAMPLE 2 THE INITIAL RESULT WAS 93.06 PG/ML. THE REPEAT RESULT WAS 198.2 PG/ML. ON (B)(6) 2023: THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER DEEMED THE INITIAL RESULT HIGH WHICH PROMPTED THE RERUN OF THE PATIENT SAMPLE. SAMPLE 3 THE INITIAL RESULT WAS >2000 PG/ML. THE FIRST REPEAT RESULT WAS 410.9 PG/ML. THE SECOND REPEAT RESULT WAS 314.6 PG/ML. THE THIRD REPEAT RESULT WAS 339.2 PG/ML.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS E411 DISK IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND PERFORMED AN ASSAY PERFORMANCE TEST. THE FSE CHANGED THE SAMPLE AND REAGENT PROBES. THE CUSTOMER USED A NEW REAGENT PACK AND PERFORMED A CALIBRATION WITH SUCCESSFUL RESULTS. THE INVESTIGATION IS ONGOING.