ELECSYS CMV IGG

Additional Manufacturer Narrative

THE COBAS E602 MODULE SERIAL NUMBER WAS (B)(6). THE CUSTOMER USES A 3RD PARTY QC. QC WAS WITHIN RANGE. THE CALIBRATION WAS LAST DONE ON 26-SEP-2023 AND WAS OUTSIDE THE RECOMMENDED CALIBRATION FREQUENCY. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS CYTOMEGALOVIRUS - CMV IGG ASSAY ON A COBAS 8000 - COBAS E602 IMMUNOASSAY ANALYZER. INITIAL RESULT: 2.12 U/ML (POSITIVE). ON (B)(6) 2024, A NEW SAMPLE WAS DRAWN FROM THE PATIENT FOR VERIFICATION AND THE 1ST REPEAT RESULT WAS 0.150 U/ML (NEGATIVE). ON (B)(6) 2024, THE PATIENT CONTACTED THE LABORATORY QUESTIONING THE RESULTS. ON THE SAME DAY, THE ORIGINAL SAMPLE AND THE SAMPLE FROM (B)(6) 2024 WERE REPEATED AND THE RESULTS WERE BOTH 0.150 U/ML (NEGATIVE). ON (B)(6) 2024, THE ORIGINAL SAMPLE AND THE SAMPLE FROM (B)(6) 2024 WERE REPEATED IN A DIFFERENT LABORATORY USING A NON-ROCHE CMV IGG TEST AND THE RESULTS WERE BOTH <0.2 AU/ML (NEGATIVE).

Additional Manufacturer Narrative

A GENERAL REAGENT PROBLEM CAN BE EXCLUDED BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.