TPUC3

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TPUC3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 15.2 MG/DL. THE REPEATED RESULT WAS 8.4 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER TO ENSURE THE RESULT OF 8.4 MG/DL WAS CORRECT. THE RESULT OBTAINED ON THE OTHER ANALYZER WAS NOT PROVIDED. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED DUE TO QC BEING OUT OF RANGE AFTER THE SAMPLE WAS PROCESSED. THE REPEATED RESULT OF 8.4 MG/DL WAS BELIEVED TO BE CORRECT.

Additional Manufacturer Narrative

THE CALIBRATION DATA SHOWED "STD.E" ALARMS. THE FIELD SERVICE REPRESENTATIVE FOUND THE CUSTOMER HAD NOT UPDATED THE CALIBRATOR TO THE NEW LOT. THE CUSTOMER CORRECTED THE CALIBRATOR LOT NUMBER AND ADJUSTED THE QC. THE FIELD SERVICE REPRESENTATIVE INSPECTED THE SYSTEM AND PERFORMED CHECKS WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.