ELECSYS CA 19-9

Additional Manufacturer Narrative

DATA ANALYSIS REVEALED THAT THE CALIBRATION AND QC WERE WITHIN THE ACCEPTABLE RANGE. THEREFORE, A GENERAL REAGENT PROBLEM COULD BE EXCLUDED AS THE QC WITHIN THE RANGE ON THE DATE OF EVENT. IT WAS REPORTED THAT A FIELD SERVICE ENGINEER WAS DISPATCHED AND CHANGED THE GEAR PUMP HEAD AND THE MEASURING CELLS SINCE THE LIFETIME THRESHOLD WAS REACHED, AND ONE MEASURING CELL HAD MORE THAN 100000 TESTS. NO FURTHER ISSUES WERE REPORTED. AS NO FURTHER INFORMATION WAS PROVIDED, THE ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 19-9 ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS <10000 U/ML. THE REPEAT RESULTS WERE <10000 AND 46.3 U/ML WITH DILUTION.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE FIELD SERVICE ENGINEER (FSE) REPLACED THE GEAR PUMP HEAD AND THE MEASURING CELLS SINCE THE LIFETIME THRESHOLD WAS REACHED, AND ONE MEASURING CELL HAD MORE THAN 100000 TESTS. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

H6 CODING (MEDICAL DEVICE PROBLEM CODE) HAS BEEN UPDATED.