ELECSYS AMH

Additional Manufacturer Narrative

THE E402 ANALYZER SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. NO SAMPLE INVERSIONS WERE PERFORMED AND THE CUSTOMER USED A CLOTTING TIME OF "UP TO 15 MINUTES." THE CUSTOMER USED A CENTRIFUGATION TIME OF 5 MINUTES AT A SPEED OF 4000 REVOLUTIONS PER MINUTE (RPM). THE CLOTTING AND CENTRIFUGATION TIMES MAY BE TOO SHORT. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS AMH (AMH) ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 17.4 NG/ML. THE REPEAT RESULT WAS < 0.0100 NG/ML WITH A DATA FLAG. THE PATIENT WAS TESTED IN A DIFFERENT LABORATORY AND THE RESULT FROM THE MAGLUMI METHOD WAS 0.049 NG/ML. THE ORIGINAL SAMPLE WAS REPEATED AT THE LABORATORY USING THE MAGLUMI METHOD AND THE REPEAT RESULT WAS 0.056 NG/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PRE-ANALYTICAL HANDLING ISSUE (NO TUBE INVERSIONS AFTER DRAW, TOO SHORT CLOTTING TIME AND POSSIBLY IMPROPER CENTRIFUGATION).