ELECSYS AMH SYSTEM

Additional Manufacturer Narrative

THE INSTRUMENT PERFORMANCE TESTING WAS WITHIN SPECIFICATION AFTER THE EVENT. THE INVESTIGATION DETERMINED THE SAMPLE INVERSION, CLOTTING TIME, AND CENTRIFUGATION SPEED WERE INSUFFICIENT FOR THE TUBE TYPE. THE CUSTOMER DID NOT USE RACK ADAPTERS WHICH ARE REQUIRED FOR USE WITH 13 MM. DIAMETER TUBES. THE PROVIDED ALARM TRACE CONTAINS SEVERAL SAMPLE LIQUID LEVEL DETECTION ALARMS WHICH INDICATES A POSSIBLE SAMPLE QUALITY ISSUE. BASED ON THE PROVIDED DATA, A GENERAL REAGENT ISSUE IS NOT EVIDENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS NOT MATCHING THE CLINICAL PICTURE FOR 2 PATIENTS TESTED FOR ELECSYS AMH PLUS (AMH PLUS) ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE HIGH RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE DOCTOR STATED THE RESULTS WERE NOT POSSIBLE. THE CUSTOMER NOTED THAT THE PATIENTS WERE NOT TAKING THE MEDICATION REKOVELLE. IT IS NOT CLEAR HOW THIS RELATES TO THE QUESTIONABLE AMH PLUS RESULTS. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE CUSTOMER'S CALIBRATION FREQUENCY IS VERY LOW. THE CUSTOMER HAS NOT PROVIDED ANY QC DATA FROM THE TIME OF THE PATIENT RESULTS. THE QC DATA THAT WAS PROVIDED SHOWS VERY HIGH RESULTS WITH SUBOPTIMAL RECOVERY. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. THE CUSTOMER USES 13 MM SAMPLE TUBES WITH NO RACK ADAPTERS.