TOTAL PROTEIN URINE/CSF GEN.3

Additional Manufacturer Narrative

THE CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025. THE PROVIDED QC SHOWED RESULTS OUTSIDE THE ACCEPTABLE RANGE. THE ALARM TRACE SHOWED AN ABNORMAL ASPIRATION ALARM. THE CUSTOMER WAS ASSISTED VIA TELEPHONE, AND IT WAS FOUND THAT THE CUSTOMER WAS USING THE INCORRECT CALIBRATOR. THE CUSTOMER PERFORMED CALIBRATION WITH THE REQUIRED CALIBRATOR, PRECISION STUDIES, AND SAMPLE TESTING WITH SUCCESSFUL RESULTS. THE TROUBLESHOOTING ACTION PERFORMED DURING THE CUSTOMER'S ASSISTANCE RESOLVED THE ISSUE.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 ASSAY ON A COBAS 8000 COBAS C 502 MODULE. INITIAL RESULT: 19.9 MG/DL. MULTIPLE CALIBRATOR FAILURES PROMPTED THE REPEAT OF THE SAMPLE ON A DIFFERENT ANALYZER. REPEAT RESULT: 8.8 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULT WAS ISSUED.

Additional Manufacturer Narrative

THE COBAS C 502 MODULE SERIAL NUMBER WAS (B)(6). THE SAMPLE WAS A URINE SAMPLE. THE CALIBRATION FAILED AFTER THE REAGENT PACK WAS CHANGED. THE INVESTIGATION IS ONGOING.