UNICEL® DXC 800 SYNCHRON® SYSTEM

Description of Event or Problem

A CUSTOMER REPORTED THAT ERRONEOUS, LOW ASPARTATE AMINOTRANSFERASE (AST) RESULTS WERE GENERATED ON TWO UNICEL DXC 800 SYNCHRON SYSTEMS FOR TWO PATIENT SAMPLES OVER TWO DAYS. THIS REPORT IS TWO OF TWO AND REPRESENTS THE ERRONEOUS AST RESULT GENERATED ON A UNICEL DXC 800 SYNCHRON SYSTEM WITH SERIAL NUMBER (B)(4) FOR ONE PATIENT SAMPLE ON (B)(6) 2011. THE INITIAL AST RESULT WAS LOW AND BELOW THE ASSAY'S NORMAL REFERENCE RANGE. UPON SUBSEQUENT REPEAT TESTING ON THE SAME AND ANOTHER INSTRUMENT, THE REPEAT RESULTS WERE HIGHER, WITHIN THE ASSAY'S NORMAL REFERENCE RANGE, CONCURRED WITH EACH OTHER, AND WERE REGARDED AS VALID. THE INITIAL AST RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AND HENCE THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE INSTRUMENT AST QUALITY CONTROL (QC) RESULTS DURING THE TIME FRAME OF THE EVENT RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATIONS HOWEVER THE CUSTOMER INDICATED THAT THE WEEK PRIOR THEY HAD EXPERIENCED QC ISSUES WITH THIS ASSAY. THE CUSTOMER DID NOT REPORT ANY ISSUES WITH OTHER CHEMISTRIES AND THE OTHER CHEMISTRY RESULTS PROVIDED FOR THIS PATIENT BY THE CUSTOMER ARE NOT IN QUESTION. THE SAMPLE WAS A SERUM SAMPLE.

Additional Manufacturer Narrative

SERVICE WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE SYRINGE AND PROBE. THE INSTRUMENT WAS RETURNED BACK INTO OPERATION AFTER COMPLETION OF THE NECESSARY REPAIRS. THE ROOT CAUSE OF THIS ISSUE APPEARS TO BE HARDWARE RELATED. MDRS ASSOCIATED WITH THIS EVENT: 2050012-2011-06976, 2050012-2011-06977.