ALBUMIN GEN.2

Additional Manufacturer Narrative

THE COBAS 6000 C (501) MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF 10 QUESTIONABLE ALBUMIN GEN.2 RESULTS FROM THE COBAS 6000 C (501) MODULE. ONLY THE DATA FOR 2 OF THE PATIENTS WERE PROVIDED, AND ARE A REPORTABLE MALFUNCTION. PATIENT 1'S INITIAL RESULT WAS 0.42 G/DL, AND THE REPEAT RESULT FROM ANOTHER INSTRUMENT WAS 4.22 G/DL PATIENT 2'S INITIAL RESULT WAS 0.47 G/DL, AND THE REPEAT RESULT FROM ANOTHER INSTRUMENT WAS 4.78 G/DL. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. THE INITIAL RESULTS WERE REPEATED BECAUSE THE DOCTOR OR TECHNICIAN QUESTIONED THE CRITICAL RESULTS.

Additional Manufacturer Narrative

A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE REAGENT PACK NEEDED TO BE RECALIBRATED. THE FSE CHECKED THE PROBE ALIGNMENTS, THE GEAR PUMP PRESSURE WAS ADJUSTED, THERE WERE NO LEAKS FOUND, AND THE RINSE HEAD MECHANISM NOZZLES WERE CHECKED AND WERE OKAY. QC AND PRECISION WERE COMPLETED AND PASSED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.