TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION

Additional Manufacturer Narrative

THE COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 9.0%, AND THE REPEAT RESULT WAS 5.5%. THE QUESTIONABLE RESULT WAS REPEATED BECAUSE THE CUSTOMER NOTICED THAT IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

Additional Manufacturer Narrative

IN THE ALARM TRACE, THERE WAS AN ALARM THAT THE WATER RESERVOIR LEVEL WAS TOO LOW AND AN ALARM FOR THE INCUBATION BATH WATER LEVEL SENSOR. QC AND CALIBRATION WERE PASSING. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE GEAR PUMP PRESSURE WAS SLIGHTLY LOW. THE FSE DECONTAMINATED THE ENTIRE ANALYZER, REPLACED ALL PIPETTOR SEALS, VACUUM VALVES, THE RINSE MECHANISM TUBING, DETERGENT VACUUM TUBING, ALL CELLS, VACUUM DIAPHRAGMS, FLAPPER VALVES, AND THE GEAR PUMP HEAD. HE VERIFIED THAT ALL MECHANISMS WERE ADJUSTED AND WORKING PROPERLY, VERIFIED ALL WATER AND VACUUM PRESSURES, AND RAN CALIBRATION AND QC THAT PASSED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. THE CUSTOMER HAS NOT REPORTED ANY ADDITIONAL ISSUES AFTER THE SERVICE WAS PERFORMED.