ALBUMIN GEN.2

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE DATA PROVIDED, A GENERAL REAGENT, CALIBRATION, OR HARDWARE ISSUE WAS EXCLUDED. AN ISSUE WITH THE INDIVIDUAL REAGENT CASSETTE WAS LIKELY THE CAUSE AS NO OTHER COMPLAINTS FOR THIS LOT OF REAGENT HAVE BEEN RECEIVED AND THE USE OF ANOTHER CASSETTE SOLVED THE ISSUE.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE LOW ALB2 ALBUMIN GEN. 2 RESULTS FOR QC MATERIAL AND UP TO 10 PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER AT THE SITE. OF THE DATA PROVIDED FOR TWO PATIENT SAMPLES, ONLY THE RESULTS FOR ONE PATIENT SAMPLE WERE DISCREPANT. THE INITIAL RESULT WAS 2.3 G/DL AND THE REPEAT RESULT WAS 2.9 G/DL. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT AND CORRECTED REPORTS WERE SENT. THE CUSTOMER DID NOT HAVE ANY INFORMATION REGARDING AN ADVERSE EVENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER REPLACED THE REAGENT PACK AND QC RECOVERY WAS THEN IN RANGE. THEY REPEATED TESTING AND OBTAINED RESULTS COMPARABLE TO RESULTS ON OTHER ANALYZER. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. CALIBRATION AND QC RESULTS PASSED. THE CUSTOMER USED COBAS 8000 C 702 MODULE SERIAL NUMBER (B)(4).