ELECSYS ESTRADIOL III ASSAY

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH ELECSYS ESTRADIOL III ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM). PATIENT 1: INITIAL RESULT: >3000 PG/ML (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 156.1 PG/ML (TESTED WITH AN AUTODILUTION BY THE ANALYZER WITH A DILUTION FACTOR OF 1:10). 2ND REPEAT RESULT: 15.38 PG/ML (TESTED AFTER REPLACING A NEW REAGENT PACK AND PERFORMING CALIBRATION). PATIENT 2: INITIAL RESULT: 401 PG/ML. 1ST REPEAT RESULT: 516 PG/ML (TESTED WITH AN AUTODILUTION BY THE ANALYZER WITH A DILUTION FACTOR OF 1:10). 2ND REPEAT RESULT: 514.6 PG/ML (TESTED WITH A MANUAL DILUTION WITH A DILUTION FACTOR OF 1:10). PATIENT 3: INITIAL RESULT: 112 PG/ML. 1ST REPEAT RESULT: 370.8 PG/ML (TESTED WITH AN AUTODILUTION BY THE ANALYZER WITH A DILUTION FACTOR OF 1:10). 2ND REPEAT RESULT: 353.0 PG/ML (TESTED WITH A MANUAL DILUTION WITH A DILUTION FACTOR OF 1:10). INCONSISTENT DILUTION RESULTS PROMPTED THE REPEAT OF THE SAMPLES FOR PATIENT 1, PATIENT 2, AND PATIENT 3. THE FOLLOWING RESULTS WERE DEEMED TO BE CORRECT AND REPORTED OUTSIDE THE LABORATORY: PATIENT 1: 15.38 PG/ML. REPORTEDLY, AN AMENDED REPORT WITH THIS RESULT WAS ISSUED. PATIENT 2: 401 PG/ML. PATIENT 3: 112 PG/ML.

Additional Manufacturer Narrative

THE COBAS E 411 ANALYZER (DISK SYSTEM) SERIAL NUMBER WAS (B)(6). THE INSTRUMENT TRIGGERED A DILUTION FOR A > VALUE, WHEN A DILUTION WAS UNNECESSARY. THE CUSTOMER THEN REPLACED THE REAGENT PACK WITH A NEW ONE. AN INSTRUMENT CHECK WAS PERFORMED, AND IT WAS WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.