AMH ELECSYS E2G 100

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT TESTED WITH ELECSYS AMH ASSAY ON A COBAS 6000 E 601 MODULE (SERIAL NUMBER (B)(4)). THE INITIAL RESULT WAS 0.773 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE PATIENT COMPLAINED. ON (B)(6) 2023 THE PATIENT WENT TO A DIFFERENT LABORATORY (LABORATORY A) WHERE THE RESULT WAS 25 NG/ML. ON (B)(6) 2023 THE REPEAT RESULT FROM THE E 601 MODULE WAS 0.777 NG/ML. THE CUSTOMER SENT THE SAMPLE TO 2 DIFFERENT LABORATORIES USING THE ROCHE METHOD. THE RESULT FROM LABORATORY B WAS 16.5 NG/ML. THE RESULT FROM LABORATORY C WAS 25 NG/ML. THE HIGHER RESULTS WERE BELIEVED TO BE CORRECT.

Additional Manufacturer Narrative

INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

H6 CODES WERE UPDATED. THE INVESTIGATION DETERMINED THAT BASED ON THE AVAILABLE INFORMATION AND DATA, THE ROOT CAUSE FOR THE OBSERVED DISCREPANCIES CANNOT BE IDENTIFIED. HOWEVER, BASED ON THE RESULT CONSTELLATIONS OF REPRODUCIBLE CLEARLY DIFFERENT AMH RESULTS FOR THE SAME PATIENT AND SAME DRAW AT THE 2 SITES, A MIXING UP OF SAMPLES SHOULD BE LOCALLY CONSIDERED AS A POSSIBLE ROOT CAUSE. A PIPETTING ISSUE WITH THE FIRST RESULTS (NON-REPRODUCIBLE FALSE LOW RESULTS) CANNOT BE ENTIRELY EXCLUDED. NO GENERIC REAGENT ISSUE WAS FOUND.