TPUC3

Additional Manufacturer Narrative

THE TPUC3 REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE C702 MODULE SERIAL NUMBER WAS (B)(6). THE CUSTOMER USES A 3RD PARTY QC. QC WAS WITHIN THE ASSIGNED RANGES ON THE DAY OF THE EVENT. THE ALARM TRACE SHOWED MULTIPLE ABNORMAL ASPIRATION (SAMPLE PROBE) ALARMS, A SAMPLE CLOT ALARM, AND A COUPLE OF SAMPLE SHORT ALARMS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ASSAY ON A COBAS 8000 C702 MODULE. RANDOM RESULT: 21.7 MG/DL. 24 HOURS RESULT: 0.0 MG/DAY. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE RESULT OF 21.7 MG/DL WAS REPORTED OUTSIDE THE LABORATORY.

Additional Manufacturer Narrative

THERE WAS FLUCTUATION AT THE BEGINNING OF THE CALIBRATION TRACE BUT THEN IT BECAME STABLE WITHIN SPECIFICATIONS. THE REACTION KINETICS SHOWED A VERY STRONG ABNORMAL COURSE. SUCH CURVES ARE USUALLY TRIGGERED BY GAMMOPATHY. GAMMOPATHY IS INCREASINGLY OBSERVED IN PATIENTS DIAGNOSED WITH CANCER, WHICH WAS SUPPORTED IN THIS EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH A SAMPLE-RELATED (E.G. GAMMOPATHY) AND A PREANALYTIC ISSUE AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY.