ALB2 ALBUMIN GEN.2

Additional Manufacturer Narrative

(B)(6). (B)(4).

Description of Event or Problem

THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR ALB2 ALBUMIN GEN.2 (ALB) ON TWO COBAS 6000 C (501) MODULE - C501 ANALYZERS. AN ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT AND THE PHYSICIAN. THE SAMPLE INITIALLY RESULTED AS 37.1 G/L. THE SAMPLE WAS REPEATED ON A SECOND C501 ANALYZER, RESULTING AS 37.4 G/L. THE SAMPLE WAS REPEATED ON AN ABBOTT ARCHITECT ANALYZER, RESULTING AS 26.4 G/L. THE PHYSICIAN INDICATED THAT THE LOW RESULT OBTAINED WITH THE ARCHITECT ANALYZER WAS MORE IN LINE WITH THE MEDICAL STATE OF THE PATIENT AND THE ELECTROPHORESIS RESULTS OF THE PATIENT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBERS OF THE C501 ANALYZERS WERE ASKED FOR, BUT NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. IT WAS ASSUMED THAT BLOOD PROTEINS RELATED TO GAMMOPATHY WERE PRESENT IN THE SAMPLE AND INTERFERED WITH THE ALB ASSAY. AS NO SAMPLE WAS AVAILABLE, FURTHER INVESTIGATIONS WERE NOT POSSIBLE.