ELECSYS ACTH

Description of Event or Problem

THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS CORTISOL II AND ELECSYS ACTH TEST SYSTEM (ACTH) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. THIS MEDWATCH IS FOR THE ELECSYS ACTH TEST SYSTEM (ACTH) ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS CORTISOL II ASSAY REPORT. THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 626.6 PG/ML. THE REPEAT RESULT WAS 581.0 PG/ML. THE RESULT OF A NEW PATIENT SAMPLE WAS 7.33 PG/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PREVIOUS RESULTS, PROMPTING THE PATIENT SAMPLE TO BE RERUN. THE RESULT OF THE NEW PATIENT SAMPLE WAS DEEMED CORRECT.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 6000 E 601 MODULE IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE AND CLEANED AND ADJUSTED THE TUBING OF THE EXTRA WASH STATION (EWS). THE CUSTOMER PERFORMED CALIBRATION AND QC WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE CALIBRATION RESULTS WERE ACCEPTABLE. THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THE ALARM TRACE DID NOT INDICATE ANY ISSUES. THE PATIENT SAMPLE WAS CENTRIFUGED FOR FIVE MINUTES. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT DETECTED BECAUSE THE QC BEFORE THE EVENT WAS WITHIN RANGE; ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. THE EVENT'S CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.