ALTP GEN.2

Additional Manufacturer Narrative

THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ALTP GEN.2 RESULTS FOR ONE PATIENT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 18.5 U/L. THE REPEAT RESULT USING A COBAS 8000 ANALYZER WAS 34 U/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING AND SAMPLE QUALITY ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. GENERAL REAGENT, CALIBRATOR, OR ANALYZER ISSUES WERE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.