COBAS INTEGRA 400

Description of Event or Problem

THE USER STATED THEY HAVE HAD "AT LEAST 5 OCCURRENCES" OF A HIGH HEMOGLOBIN A1C RESULT WHICH WAS REPORTED, THEN REPEATED AS NORMAL. THE DOCTORS HAVE STATED THE PATIENTS WITH THE HIGH RESULTS HAVE NO OTHER INDICATION THAT WOULD CAUSE A HIGH RESULT. THE PATIENTS HAD NOT BEEN TREATED AS "THE DOCTORS FELT THE PATIENTS HAD NOT BEEN THAT HIGH AND NOTIFIED THE LAB, RESULTING IN THE REPEAT TESTING." THE USER PROVIDED THREE EXAMPLES. ON (B)(6)2009, A SAMPLE FOR A FEMALE PATIENT RESULTED 13.6% INITIALLY AND 7.56% UPON REPEAT. ON (B)(6)2009, A SAMPLE FOR A FEMALE PT RESULTED 11.8% INITIALLY AND 6.2% UPON REPEAT. ON (B)(6)2009, A SAMPLE FOR A MALE PATIENT RESULTED 14.1% INITIALLY AND 7.4% UPON REPEAT. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE AND CHECKED THE ANALYZER BY PERFORMING PIPETTING AND PHOTOMETER CHECKS WITH ACCEPTABLE RESULTS. HE ALSO CHECKED THE CONFIGURATION OF THE ASSAY AND RAN EIGHT SPECIMENS AND COULD NOT DUPLICATE THE ISSUE.