ELECSYS ANTI-CCP

Additional Manufacturer Narrative

IN THE INITIAL MDR'S B5 DESCRIBE EVENT OR PROBLEM, THE LINES "THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE." SHOULD HAVE BEEN: "THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER THAT USES THE ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA), AND THE RESULT WAS NEGATIVE." THE CUSTOMER STATED THAT THE POSITIVE ELECSYS ANTI-CCP RESULTS DID NOT FIT THE CLINICAL PICTURE. ON (B)(6) 2025, THE CUSTOMER PROVIDED NEW ELECSYS ANTI-CCP REPEAT RESULTS FOR THE FOLLOWING PREVIOUSLY REPORTED PATIENT SAMPLES. THE LABORATORY METHOD AND UNIT OF MEASUREMENT WERE NOT PROVIDED. FOR SAMPLE 3, THE INITIAL RESULT WAS 68.3 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER, AND THE RESULT WAS NEGATIVE. ON (B)(6) 2025, THE REPEAT RESULT WAS 32.5. FOR SAMPLE 4, THE INITIAL RESULT WAS 45.9 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER, AND THE RESULT WAS NEGATIVE. ON (B)(6) 2025, THE REPEAT RESULT WAS 26.5. FOR SAMPLE 5, THE INITIAL RESULT WAS 46 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER, AND THE RESULT WAS NEGATIVE. ON (B)(6) 2025, THE REPEAT RESULT WAS 21.8. ON (B)(6) 2025, THE CUSTOMER PROVIDED SIX NEW QUESTIONABLE ELECSYS ANTI-CCP RESULTS. THE LABORATORY METHOD AND UNIT OF MEASUREMENT WERE NOT PROVIDED. FOR SAMPLE 6, THE INITIAL RESULT WAS 65 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 26.9. FOR SAMPLE 7, THE INITIAL RESULT WAS 63.6 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 28.7. FOR SAMPLE 8, THE INITIAL RESULT WAS 53.2 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 52.3. FOR SAMPLE 9, THE INITIAL RESULT WAS 189 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 35.3. FOR SAMPLE 10, THE INITIAL RESULT WAS 67.5 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 24.2. FOR SAMPLE 11, THE INITIAL RESULT WAS 76.9 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 27.3. THE SAMPLES WERE RECEIVED FOR INVESTIGATION AND WERE TESTED FOR THE PRESENCE OF INTERFERENTS. FOR SIX OF THE PATIENT SAMPLES, THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH A STREPTAVIDIN INTERFERENT IN THE PATIENT SAMPLES. FOR FIVE OF THE PATIENT SAMPLES, THE INVESTIGATION CONFIRMED THE CUSTOMER¿S ELECSYS ANTI-CCP RESULTS. HOWEVER, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. PER PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-CCP RESULTS FOR 5 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. THE DOCTOR STATED THAT THE RESULTS DO NOT MATCH THE CLINICAL STATUS OF THE PATIENTS. FOR SAMPLE 1, THE INITIAL RESULT WAS 91.6 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE. FOR SAMPLE 2, THE INITIAL RESULT WAS 157 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE. FOR SAMPLE 3, THE INITIAL RESULT WAS 68.3 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE. FOR SAMPLE 4, THE INITIAL RESULT WAS 45.9 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE. FOR SAMPLE 5, THE INITIAL RESULT WAS 46 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE. THE EXACT DATES OF TESTING WERE NOT PROVIDED.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE PATIENT SAMPLES WERE REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.