ELECSYS VITAMIN B12 II

Additional Manufacturer Narrative

SECTION D PRODUCT INFORMATION HAS BEEN UPDATED, AS WELL AS G1 MANUFACTURING SITE AND G4. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION DATA FOR THE E 801 WAS ACCEPTABLE. THE QCS FOR THE E 801 WERE WITHIN THE +/-3 STANDARD DEVIATION (SD) RANGE FROM (B)(6) 2024. THE ALARM TRACE SHOWED SEVERAL CLOT DETECTION ERRORS. IT WAS FOUND THAT THE CUSTOMER USES A FIXED CENTRIFUGE THAT CAN LEAD TO SLANTED SAMPLE SEDIMENT, WHICH CAN IMPACT THE SAMPLE QUALITY. IT WAS ALSO FOUND THAT SEVERAL OPERATOR MAINTENANCE ACTIONS ON THE ANALYZER WERE DUE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO SSU E 801 MODULE. ON (B)(6) 2024, THE INITIAL VITAMIN B12 RESULT WAS 101 PG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 100 PG/ML WITH FLAG. THE RESULTS WERE DEEMED INCORRECT. ON (B)(6) 2024, THE SAMPLE WAS REPEATED ON AN E601 ANALYZER. THE INITIAL VITAMIN B12 RESULT WAS 201.8 PG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 178.4 PG/ML. THE RESULT OF 201.8 PG/ML WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.