LIPASE COLORIMETRIC ASSAY

Additional Manufacturer Narrative

THE COBAS C 303 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE CUSTOMER REPORTED THAT QC MEASURED WITH THE REAGENT LOT 907469 WAS TOO HIGH. THE QC MEASURED WITH THE REAGENT LOT 920585 WAS WITHIN SPECIFICATIONS. THE CUSTOMER IMPLEMENTED AN EXTRA WASH STEP (EWS) AND USED A NEW CALIBRATOR LOT. THE CUSTOMER REPORTED THAT THESE ACTIONS HAVE IMPROVED THE MACHINE'S PERFORMANCE. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE AS AN OVERALL INSTRUMENT PERFORMANCE ANALYSIS WAS NOT POSSIBLE.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE LIPASE COLORIMETRIC ASSAY RESULT FROM THE COBAS C 303 ANALYTICAL UNIT FOR FOUR PATIENTS. PATIENT 1'S INITIAL RESULT WAS 81.3 U/L, AND THE REPEAT RESULT WAS 43.3 U/L. PATIENT 2'S INITIAL RESULT WAS 87.9 U/L, AND THE REPEAT RESULT WAS 41.7 U/L. PATIENT 3'S INITIAL RESULT WAS 89.8 U/L, AND THE REPEAT RESULT WAS 48.5 U/L. PATIENT 4'S INITIAL RESULT WAS 78.0 U/L, AND THE REPEAT RESULT WAS 32.8 U/L. THE INITIAL RESULTS WERE QUESTIONED BECAUSE THE PATIENTS WERE HEALTHY. THE REPEAT RESULTS WERE PERFORMED WITH A NEW REAGENT LOT ON THE SAME INSTRUMENT.