DILUENT UNIVERSAL 2

Additional Manufacturer Narrative

THE COBAS 6000 CORE UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+BETA RESULTS FROM THE COBAS 6000 CORE UNIT. THE INITIAL RESULT WAS 10000 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT USING A DILUTION WAS 15.61 MIU/ML. THE CUSTOMER REPLACED THE ONBOARD DILUENT AND REPEATED THE SAMPLE. ON (B)(6) 2026, THE REPEAT RESULT WITH A 1:100 DILUTION WAS 21089 MIU/ML. THE RESULT OF 21089 MIU/ML WAS BELIEVED TO BE CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

MEDWATCH FIELDS D1-D4, G1, AND G4 WERE UPDATED. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE ISSUE WAS CONSISTENT WITH PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THE CUSTOMER WAS NOT USING THE RECOMMENDED SAMPLE TUBE RACK ADAPTERS. THE USED DILUENT WAS NOT AT AN AMBIENT TEMPERATURE BEFORE USE AND/OR THERE WERE BUBBLES OR FOAM ON ITS SURFACE. THE DILUENT MAY HAVE BEEN CONTAMINATED. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE. A GENERAL REAGENT ISSUE WAS EXCLUDED.