ELECSYS BRAHMS PCT

Additional Manufacturer Narrative

THERE WERE MULTIPLE ALARMS IN THE ALARM TRACE THAT ARE CONSISTENT WITH POOR SAMPLE QUALITY ON THE DATE OF THE EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. A GENERAL REAGENT PROBLEM COULD NOT BE IDENTIFIED.

Additional Manufacturer Narrative

THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS(B)(6). A FIELD SERVICE ENGINEER (FSE) PERFORMED CLEANING MAINTENANCE, CHECKED RINSE LEVELS, PUMP PRESSURES, AND PROBE CONDITIONS. AN INSTRUMENT CHECK AND QC WERE PASSING. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS BRAHMS PCT RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.6 NG/ML, AND THE REPEAT RESULT ON ANOTHER E801 MODULE WAS 2.48 NG/ML. THE INITIAL RESULT WAS REPEATED AFTER THE CUSTOMER EXPERIENCED SOME QC ISSUES AND PERFORMED A PATIENT COMPARISON. THE CUSTOMER IS UNSURE WHICH RESULT IS CORRECT.