ELECSYS ANTI-CCP

Additional Manufacturer Narrative

SECTION B3 WAS UPDATED. THE CUSTOMER'S E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE INITIAL REPORT STATED: "THE SAMPLE WAS REPEATED BY A COMPETITOR METHOD (IMMUNOCAP 250) AND THE RESULT WAS 0.2 MOC (REFERENCE RANGE: 1.0)." THIS SHOULD SAY: "ON (B)(6) 2023 A NEW SAMPLE WAS OBTAINED AND TESTED BY A COMPETITOR METHOD (IMMUNOCAP 250) AND THE RESULT WAS 0.2 MOC (REFERENCE RANGE: 1.0)." THE INITIAL REPORT STATED: "ON (B)(6) 2023 THE CUSTOMER REPEATED THE ORIGINAL PATIENT SAMPLE FOR CONFIRMATION ON THE E801 ANALYZER AND THE RESULT WAS: 500 U/ML." THIS SHOULD SAY: "ON (B)(6) 2023 THE CUSTOMER REPEATED THE ORIGINAL PATIENT SAMPLE FOR CONFIRMATION FROM THE 'LONG-TERM SEROTHEQUE' AND THE RESULT WAS: 500 U/ML." THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION AND TESTED WITH ELECSYS ANTI-CCP REAGENT LOT 714474 ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER'S ANTI-CCP RESULT WAS REPRODUCED ON THE E801 ANALYZER AT THE INVESTIGATION SITE (500 U/ML WITH A DATA FLAG). THE SAMPLE UNDERWENT RHEUMAFACTOR INTERFERENCE TESTING. THE RHEUMATOID FACTOR IN THE SAMPLE WAS BELOW 14 IU/ML, AND THEREFORE WITHIN THE NORMAL RANGE (4.8 IU/ML). BASED ON THIS RESULT, THE SAMPLE WAS FURTHER TESTED FOR IGA, IGM, AND IGG TO CHECK FOR A HIGH IMMUNOGLOBULIN, HOWEVER, ALL IMMUNOGLOBULIN TESTING WAS WITHIN THE NORMAL RANGE: IGA2 = 1.22 G/L. IGG2 = 11.04 G/L. IGM2 = 1.89 G/L. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE SAMPLE WAS INVESTIGATED FURTHER WHERE AN INTERFERENCE AGAINST THE STREPTAVIDIN COMPONENT OF THE ASSAY WAS IDENTIFIED. THIS INTERFERENCE CAUSED THE HIGH ANTI-CCP RESULTS. PRODUCT LABELING STATES: "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.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-CCP (ANTI-CCP) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. THE INITIAL RESULT FROM THE E801 ANALYZER WAS > 500 U/ML. THE SAMPLE WAS REPEATED BY A COMPETITOR METHOD (IMMUNOCAP 250) AND THE RESULT WAS 0.2 MOC (REFERENCE RANGE <1.0). ON (B)(6) 2023 THE CUSTOMER REPEATED THE ORIGINAL PATIENT SAMPLE FOR CONFIRMATION ON THE E801 ANALYZER AND THE RESULT WAS > 500 U/ML.

Additional Manufacturer Narrative

THE SAMPLE WAS REQUESTED FOR INVESTIGATION.