ELECSYS VITAMIN B12 II

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN B12 II (B12 II) ON A COBAS E411 DISK ANALYZER. AFTER THE INITIAL POINT OF CONTACT, ADDITIONAL DATA WAS PROVIDED. OF THE DATA PROVIDED, DISCREPANT RESULTS WERE IDENTIFIED FOR 6 ADDITIONAL PATIENT SAMPLES TESTED ON BOTH OF THE CUSTOMER¿S E411 ANALYZERS (ANALYZER 1 AND ANALYZER 2). THE FOLLOWING RESULTS WERE OBTAINED FROM ANALYZER 1: ON (B)(6) 2024 PATIENT 1 INITIAL RESULT WAS 115.2 PG/ML. THE REPEAT RESULT WAS 288.4 PG/ML. PATIENT 2 INITIAL RESULT WAS 167.4 PG/ML. THE REPEAT RESULT WAS 355.3 PG/ML. ON (B)(6) 2024 PATIENT 3 INITIAL RESULT WAS 140.0 PG/ML. THE REPEAT RESULT WAS 248.0 PG/ML. ON (B)(6) 2024 PATIENT 4 INITIAL RESULT WAS 242.2 PG/ML. THE REPEAT RESULT WAS 178.9 PG/ML. ON (B)(6) 2024 PATIENT 5 INITIAL RESULT WAS 142.3 PG/ML. THE REPEAT RESULT WAS 224.2 PG/ML. ON (B)(6) 2024 PATIENT 6 INITIAL RESULT WAS 147.5 PG/ML. THE REPEAT RESULT WAS 212.0 PG/ML. THE FOLLOWING RESULTS WERE OBTAINED FROM ANALYZER 2: ON (B)(6) 2024 PATIENT 7 INITIAL RESULT WAS 145.2 PG/ML. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 192.8 PG/ML AND 144.6 PG/ML.

Additional Manufacturer Narrative

ANALYZER 1 SERIAL NUMBER IS (B)(6) . ANALYZER 2 SERIAL NUMBER IS (B)(6) .

Additional Manufacturer Narrative

DISCREPANT VITAMIN B12 II RESULTS WERE PROVIDED FOR 3 ADDITIONAL PATIENT SAMPLES TESTED ON ANALYZER 1: SAMPLE ID (B)(6) : ON (B)(6) 2024 THE INITIAL RESULT WAS 173.4 PG/ML. THE REPEAT RESULT WAS 254.8 PG/ML. SAMPLE ID (B)(6) : ON (B)(6) 2024 THE INITIAL RESULT WAS 219.2 PG/ML. THE REPEAT RESULT WAS 130.8 PG/ML. SAMPLE ID (B)(6) : ON (B)(6) 2024 THE INITIAL RESULT WAS < 50.00 PG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 1081 PG/ML AND 990.6 PG/ML. FOR ANALYZER 1: CALIBRATION AND QC WERE ACCEPTABLE. PREVENTIVE MAINTENANCE WAS LAST PERFORMED ON (B)(6) 2024; THE MEASURING CELL WAS REPLACED AT THAT TIME. INSTRUMENT PERFORMANCE TESTING WAS ACCEPTABLE. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. FOR ANALYZER 2: CALIBRATION AND QC WERE ACCEPTABLE. EXTENSIVE TROUBLESHOOTING WAS PERFORMED RELATED TO THE INSTRUMENT, REAGENT HANDLING, AND PRE-ANALYTICAL HANDLING; A SPECIFIC CAUSE WAS NOT FOUND. THE CALIBRATION AND QC DATA FOR BOTH INSTRUMENTS DO NOT SUGGEST A GENERAL REAGENT ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

DISCREPANT VITAMIN B12 II RESULTS WERE PROVIDED FOR AN ADDITIONAL PATIENT SAMPLE TESTED ON (B)(6) 2024 ON ANALYZER 1: THE INITIAL RESULT WAS 155.6 PG/ML. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 202.8 PG/ML AND 176.5 PG/ML.