ELECSYS CA 19-9

Additional Manufacturer Narrative

THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). A FIELD SERVICE ENGINEER (FSE) CHECKED THE INSTRUMENT BUT WAS UNABLE TO IDENTIFY THE FAILED PART. THE FSE PERFORMED A SIPPER LINE CLEANING, AND THE SEAL SUCTION PINCH VALVE AND PINCH VALVE TUBE WERE REPLACED. DISPENSATION ACCURACY WAS ALSO CONFIRMED. FUNCTION AND OPERATION CHECKS WERE PERFORMED AS A TOTAL CHECK. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. RESULTS WERE PROVIDED FOR 1 PATIENT THAT IS A REPORTABLE MALFUNCTION. THE INITIAL RESULT WAS 55.1 U/ML, AND THE REPEAT RESULT WAS 9.0 U/ML, ACCOMPANIED BY A DATA FLAG. IT WAS ASKED BUT NOT PROVIDED, WHICH OF THE RESULTS WAS BELIEVED TO BE CORRECT.

Additional Manufacturer Narrative

NO CALIBRATION INFLUENCE WAS OBSERVED. QC WAS WITHIN RANGE ON THE DATE OF THE EVENT. THERE WEREN'T ANY RELEVANT ALARMS OBSERVED IN THE ALARM TRACE REPORT PROVIDED. A FIELD SERVICE ENGINEER (FSE) REPLACED THE REAGENT PROBE AND CHANGED THE PINCH VALVE TUBING. DUE TO THE LIMITED INFORMATION AVAILABLE ABOUT THE ISSUE, THE ROOT CAUSE COULD NOT BE DETERMINED. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES.