ELECSYS TACROLIMUS

Additional Manufacturer Narrative

CALIBRATION SIGNALS WERE WITHIN EXPECTATIONS. UPON REVIEW OF THE ALARM TRACE, INSUFFICIENT SAMPLE VOLUME AND CLOT PIPETTING ERRORS WERE OBSERVED. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE COBAS E411 RACK SERIAL NUMBER WAS (B)(6). QC WAS PERFORMED AND IT WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER FOUND THAT THE SAMPLE PROBE WAS MISADJUSTED. HE ADJUSTED THE SAMPLE PROBE. PRECISION STUDIES WERE PERFORMED AND THEY WERE WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S WHOLE BLOOD SAMPLES TESTED WITH ELECSYS TACROLIMUS ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER. ON (B)(6) 2023: INITIAL RESULT: >30 NG/ML. 1ST REPEAT RESULT: 9.1 NG/ML. 2ND REPEAT RESULT: 10.2 NG/ML (TESTED ON A DIFFERENT E411). 3RD REPEAT RESULT: 9.7 NG/ML (TESTED ON A DIFFERENT E411). ON (B)(6) 2023: INITIAL RESULT: 9.4 NG/ML. 1ST REPEAT RESULT: 5.6 NG/ML (NEW TREATED SAMPLE). 2ND REPEAT RESULT: 6.1 NG/ML (TESTED ON A DIFFERENT E411). THE CUSTOMER NOTICED THAT THE RESULTS DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE SAMPLES WERE REPEATED. ALL THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. THE REPEAT RESULTS OF 9.1 NG/ML AND 5.6 NG/ML WERE REPORTED OUTSIDE THE LABORATORY.