LIPASE COLORIMETRIC ASSAY

Additional Manufacturer Narrative

BASED ON THE CONSISTENT RESULTS ACROSS TWO DIFFERENT COBAS C INSTRUMENTS, THE CAUSE OF THE EVENT WAS NOT AN INSTRUMENT OR REAGENT ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH A PHYSIOLOGICAL OR A PREANALYTICAL ISSUE AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH LIPASE COLORIMETRIC ASSAY ON A COBAS C 503 ANALYTICAL UNIT, NOT CONSISTENT WITH THE PATIENT'S CONDITION. INITIAL RESULT: 615 U/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT WAS HIGH AND WAS NOT CONSISTENT WITH THE PATIENT'S CONDITION. THE PHYSICIAN REQUESTED A NEW SAMPLE TO BE DRAWN AND TESTED ON THE SAME COBAS C 503 ANALYTICAL UNIT, RESULTING IN A VALUE OF 86 U/L. THE ORIGINAL SAMPLE WAS THEN REPEATED ON A DIFFERENT COBAS ANALYTICAL UNIT AT THE CUSTOMER'S SITE, AND THE VALUE OF 615 U/L WAS CONFIRMED. THE SPECIFIC RESULT RECEIVED WAS NOT PROVIDED.

Additional Manufacturer Narrative

THE LIPASE REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS: (B)(6). THE INVESTIGATION IS ONGOING.