TINA-QUANT ¿2-MICROGLOBULIN

Additional Manufacturer Narrative

THE CALIBRATION AND QC WERE WITHIN SPECIFICATIONS. THE FIELD SERVICE REPRESENTATIVE CORRECTLY PROGRAMMED ALL SPECIAL WASH FUNCTIONS BEFORE PIPETTING. CALIBRATIONS AND QCS WERE PERFORMED AND THE RESULTS WERE WITHIN SPECIFICATIONS. NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

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 TINA-QUANT 2-MICROGLOBULIN RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C 502 MODULE. PATIENT 1: THE INITIAL RESULT WAS INVALIDATED DUE TO HAVING A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY DILUTED AND THE RESULT WAS 6.4 MG/L. THE SAMPLE WAS MANUALLY DILUTED AND THE RESULT WAS 16.8 MG/L. THIS RESULT WAS BELIEVED TO BE CORRECT. PATIENT 2: THE INITIAL RESULT WAS INVALIDATED DUE TO HAVING A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY DILUTED AND THE RESULT WAS 7.2 MG/L. THE SAMPLE WAS MANUALLY DILUTED AND THE RESULT WAS 16.8 MG/L. THIS RESULT WAS BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED DUE TO THE INITIAL RESULT HAVING A DATA FLAG, AND HIGHER RESULTS WERE EXPECTED. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY.