UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

Additional Manufacturer Narrative

USER ERROR CONTRIBUTED OR CAUSED THIS EVENT. NO SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2050012-2011-03822 AND 2050012-2011-03823.

Description of Event or Problem

THE CUSTOMER REPORTED THAT ERRONEOUSLY HIGH TOTAL BILIRUBIN (TBIL) RESULTS WERE GENERATED FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE HOSPITAL PATIENT'S SAMPLES OVER TWO DAYS. THIS REPORT IS TWO OF TWO AND REPRESENTS THE ERRONEOUSLY HIGH TOTAL BILIRUBIN (TBIL) RESULTS GENERATED FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ON (B)(6) 2011 FOR TWO PATIENT SAMPLES. THE INITIAL TBIL RESULTS WERE SUPPRESSED VALUE WITH AN "OUT OF INSTRUMENT RANGE HIGH" INSTRUMENT FLAG. UPON REPEAT TESTING OF DILUTIONS OF THE SAMPLES, THE LABORATORY TECHNICIAN INCORRECTLY CALCULATED THE END RESULT. THE TECHNICIAN DID NOT FOLLOW THE CALCULATION INSTRUCTIONS PROVIDED IN A BECKMAN COULTER INC. TECHNICAL APPLICATIONS LETTER DATED (B)(6) 2007. DUE TO THIS ERROR, THE REPORTED RESULTS WERE TEN TIMES THE CORRECT RESULT. A PHYSICIAN QUESTIONED THE HIGH RESULTS AND THE SAMPLES WERE RETESTED ON DILUTED SAMPLES UTILIZING THE CORRECT CALCULATION TO GENERATE THE FINAL RESULT. THESE RESULTS WERE LOWER, MORE BELIEVABLE, AND REGARDED AS VALID. THE PATIENT HAD BEEN PREVIOUSLY ADMITTED TO THE HOSPITAL. IT IS UNKNOWN AS TO WHETHER HOSPITAL ADMISSION WAS BASED UPON THE INCORRECT TBIL RESULTS ASSOCIATED WITH THIS EVENT, HOWEVER FOR THE PURPOSES OF THIS REPORT IT IS ASSUMED THAT HOSPITAL ADMISSION WAS LINKED TO THE ERRONEOUS TBIL RESULTS ASSOCIATED WITH THIS EVENT. SPECIFIC PATIENT INFORMATION AND SAMPLE COLLECTION/HANDLING INFORMATION WAS NOT SUPPLIED BY THE CUSTOMER. INSTRUMENT TBIL QUALITY CONTROLS RESULTS DURING THE TIMEFRAME OF THE EVENT WERE FOUND TO BE WITHIN SPECIFICATION.