ELECSYS AMH

Additional Manufacturer Narrative

THE LAST CALIBRATION PERFORMED ON 14-AUG-2022 WAS WITHIN SPECIFICATIONS. THE QC RECOVERY WAS WITHIN -2SD AND WITHIN SPECIFICATIONS. THERE IS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE CUSTOMER SENT OUT NEW SAMPLES FOR FURTHER COMPARISON TESTING AND FOUND THEM ALL TO BE WITHIN THEIR LABORATORY'S ACCEPTABLE LIMITS. AFTER THE INSTRUMENT'S PERFORMANCE WAS VERIFIED, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER.  THE INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND DID NOT FIND ANY HARDWARE ISSUES. HE THEN PERFORMED AN INSTRUMENT CHECK WITH ACCEPTABLE RESULTS. HE DID NOT PERFORM ANY REPAIRS. THE CUSTOMER PERFORMED QC WITH ACCEPTABLE RESULTS. THE ANALYZER'S PERFORMANCE WAS VERIFIED.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS AMH (AMH) RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(4). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER WAS PERFORMING A QC INVESTIGATION FOR LOW BIAS OF THE AMH ASSAY. THE REPORTER USED OLD PROFICIENCY MATERIAL FOR REPEATS AND IT WAS CONFIRMED THAT THERE WAS A LOW BIAS. THE REPORTER THEN SENT OUT THE PATIENT SAMPLES TO A LABORATORY THAT USES A ROCHE ELECSYS ANALYZER FOR A SPLIT-SAMPLE ANALYSIS. PATIENT 1: THE INITIAL RESULT FROM THE ANALYZER WAS 6.83 NG/ML. THE REPEAT RESULT FROM THE OTHER LABORATORY WAS 11.61 NG/ML. PATIENT 2: THE INITIAL RESULT FROM THE ANALYZER WAS 12.1 NG/ML. THE REPEAT RESULT FROM THE OTHER LABORATORY WAS 35.3 NG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.