ELECSYS ANTI-CCP

Additional Manufacturer Narrative

THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). SAMPLE MATERIAL WAS RECEIVED FOR INVESTIGATION AND TESTED ON AN E801 ANALYZER WITH ANTI-CCP REAGENT LOT NUMBER: 860040. THE RESULT WAS 233 U/ML. THE CUSTOMER'S RESULTS WERE REPRODUCED AT THE INVESTIGATION SITE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF QUESTIONABLE HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR ELECSYS ANTI-CCP (ANTI-CCP) ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2025, THE RESULT FROM THE E801 ANALYZER WAS 217 U/ML. THIS SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE THERMO FISHER METHOD, AND THE RESULT WAS "IN THE REFERENCE RANGE." THE SPECIFIC RESULT WAS NOT PROVIDED. ON (B)(6) 2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT FROM THE E801 ANALYZER WAS 235 U/ML. ON (B)(6) 2025, THE REPEAT RESULT FROM THE E801 ANALYZER WAS 236 U/ML. THIS SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE THERMO FISHER METHOD, AND THE RESULT WAS 1 U/ML (REFERENCE RANGE 0 ¿ 10 U/ML).

Additional Manufacturer Narrative

UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT WAS CONFIRMED. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.