TINA-QUANT HBALC GEN. 3

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE HBA1C TQ GEN.3 RESULTS ON A COBAS INTEGRA 400 PLUS ANALYZER. DUE TO A CLIENT QUESTIONING REPORTED HBA1C RESULTS, THE REPORTER REPEATED PREVIOUS PATIENT SAMPLES ON THE SAME ANALYZER. FOR PATIENT SAMPLE #(B)(6), THE INITIAL HBA1C RESULT WAS 8.1%. THE REPEAT HBA1C RESULT WAS 6.4%. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS COLLECTED AND INITIALLY RUN ON (B)(6) 2022. THE REPEAT TEST WAS PERFORMED ON THE SAME SAMPLE AND ANALYZER ON (B)(6) 2022. THE INSTRUMENT SERIAL NUMBER IS (B)(4).

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) PERFORMED A PRECISION STUDY THAT WAS ACCEPTABLE. THE FSE FOUND THAT WASH PROBE C HAD FAILED THE THROUGHPUT CHECK AND WAS NOT DISPENSING FLUID. HE REPLACED TWO VALVES, RESEATED AND REPLACED BOARDS, AND REPLACED THE CASSETTE SENSE LOCK MODULE. THE CUSTOMER SUCCESSFULLY PERFORMED CALIBRATION AND QC. AS THE QC RECOVERY WAS WITHIN 2SD, THERE WAS NO INDICATION OF A PERFORMANCE ISSUE OF THE REAGENT. THE SERVICE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE.