ELECSYS DHEA-S

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) FOUND A KINKED PROCELL LINE. THE FSE REPLACED AND RESEATED THE PROCELL LINE. QC WAS ACCEPTABLE; HOWEVER, THE INSTRUMENT CHECK FAILED. PREVENTIVE MAINTENANCE WAS PERFORMED. MECHANICAL CHECKS PASSED. THE INSTRUMENT WAS OPERATING WITHIN SPECIFICATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE QC WAS IN RANGE PRIOR TO THE EVENT. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS DHEA-S ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: 630 UG/DL. THE QC WENT OUT OF RANGE, PROMPTING THE REPEAT OF THE SAMPLES. REPEAT RESULT: 417 UG/DL (IT IS UNCLEAR IF THIS RESULT WAS FROM THE SAME OR A DIFFERENT E 801). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.