COBAS U 601 URINE ANALYZER

Additional Manufacturer Narrative

THE DATA PROVIDED FOR INVESTIGATION INDICATE THERE WAS AN ISSUE WITH THE TUBE DETECTION SENSOR AND TUBE WITH ID (B)(6) WAS NOT DETECTED. AT THE TIME THE SAMPLE TUBES WITH IDS (B)(6) WERE MEASURED, THE DEFAULT TEST PROFILE WAS FOR THE U601 INSTRUMENT ONLY. IF THE U601 INSTRUMENT DOES NOT DETECT THE SAMPLE TUBE BUT THE U701 MODULE DOES, AN ORDER IS CREATED FOR THE U601 INSTRUMENT ONLY (SINCE IT IS THE ONLY TEST PROFILE.) THE SAMPLE TUBE WITH ID (B)(6) WAS DETECTED NORMALLY BY THE U601 INSTRUMENT AND THE MEASUREMENT WAS STARTED BUT THE SAMPLE TUBE WITH ID (B)(6) WAS NOT DETECTED BY THE U601 INSTRUMENT. SAMPLE TUBE WITH ID (B)(6) WAS DETECTED LATER BY THE U701 INSTRUMENT AND AN ORDER FOR THE U601 INSTRUMENT WAS CREATED. THERE WAS NO PATIENT SAMPLE MISMATCH AS SAMPLE TUBE WITH ID (B)(6) WAS NOT MEASURED; THERE WAS A MISMATCH BETWEEN THE SEQUENCE NUMBER GENERATED BY THE INSTRUMENT AND THE SEQUENCE NUMBER ASSIGNED TO THE TUBES BY THE OPERATOR. THE ISSUE WAS RESOLVED AT THE CUSTOMER SITE BY ADJUSTING THE TUBE DETECTION SENSOR. THE SENSOR ITSELF WAS WORKING CORRECTLY. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO AN INCORRECTLY ADJUSTED TUBE DETECTION SENSOR.

Additional Manufacturer Narrative

NA.

Description of Event or Problem

THE INITIAL REPORTER ALLEGED A POSSIBLE SAMPLE MISMATCH ISSUE WITH A COBAS U601 URINE ANALYZER. THE SAMPLE IDS AFFECTED WERE (B)(6) WHEN THE ANALYZER WAS IN "SERIAL NUMBER" MODE. THE SAMPLE TUBE WAS NOT DETECTED BY THE U601 ANALYZER BUT WAS DETECTED BY THE U701 ANALYZER. THE RESULTS FROM SAMPLE TUBE ID (B)(6) APPEARED TO BE FROM A SAMPLE TUBE WITH ID (B)(6). THE PATIENT RESULTS DO NOT CORRESPOND TO THE SAMPLE IDS ON THE SAMPLE TUBES. THE OPERATOR WAS MONITORING THE ANALYZER AND NOTICED THAT SOME SAMPLE TUBES WERE NOT DETECTED BY THE U601 ANALYZER AND DELETED THE SAMPLE NUMBERS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.