COBAS AMPLISCREEN HCV TEST, V2.0 IVD

Description of Event or Problem

THE CUSTOMER IS USING THE HAMILTON MICROLAB AT PLUS 2 PIPETTOR WITH SUNPLUS VERSION 3.7R AND THE ROCHE POOLING METHODS SOFTWARE VERSION 1.3, FOR POOLING OF SAMPLES FOR TESTING WITH THE COBAS AMPLISCREEN HCV TEST, VERSION 2.0 IVD (B)(4). ACCORDING TO THE POOLING ALGORITHM, THE ARCHIVE PLATE MUST BE PLACED IN THE TRANSVERSE (PORTRAIT) POSITION ON THE INSTRUMENT DECK FOR TERTIARY (INDIVIDUAL SAMPLE) RESOLUTION OF POSITIVE POOLS. UNDER NORMAL CIRCUMSTANCES, IF THE TERTIARY RESOLUTION IS ORDERED AND THE ARCHIVE PLATE IS PLACED IN THE WRONG POSITION, THE ALARM WILL SOUND AND THE ERROR MESSAGE "PLATE BARCODE IS NOT IN ACCORDANCE WITH THE PRE-DEFINED BARCODE" WILL APPEAR. THIS MEASURE IS DESIGNED TO PREVENT OPERATOR ERRORS. HOWEVER, IF THE OPERATOR IGNORES THE ALARM AND ENTERS THE ARCHIVE PLATE ID MANUALLY, THE DILUTOR RUN WILL CONTINUE DESPITE THE ORIENTATION OF THE PLATE. IN THIS SCENARIO, SAMPLES WILL BE PIPETTED FROM THE WRONG SECTION OF THE ARCHIVE PLATE. THIS MANUAL ENTRY DOES NOT HAVE AN ERROR CODE TO INDICATE THE OPERATOR'S INTERVENTION ON THE POOLING PRINTOUT LIKE IT DOES WHEN SAMPLE OR POOL IDS ARE ENTERED MANUALLY OR WHEN THERE IS AN OPERATOR RESPONSE TO PIPETTING ERROR OR BLOOD CLOT ALARMS. THE ABSENCE OF AN ERROR CODE ON THE POOLING PRINTOUT CAN MAKE IT DIFFICULT TO TRACK ERRORS WHEN REVIEWED. ON (B)(6) 2009, THE OPERATOR ENTERED THE ARCHIVE PLATE BARCODE MANUALLY WHEN THE PLATE WAS PLACED IN THE TRANSEVERSE POSITION ON THE INSTRUMENT. THIS RESULTED IN TESTING OF THE WRONG SAMPLES. IT IS UNKNOWN IF THERE WERE ALSO LIQUID DETECTION ERRORS ASSOCIATED WITH THE HAMILTON RUN. THE TERTIARY POOLED SAMPLES WERE TESTED WITH THE COBAS AMPLISCREEN HCV TEST AND NEGATIVE RESULTS WERE REPORTED. CONSEQUENTLY, UNTESTED UNITS WERE RELEASED INTO THE BLOOD SUPPLY. THE ERROR WAS REALIZED AND THE UNITS WERE SUCCESSFULLY RECALLED ON 09 FEB 2009 AND DESTROYED. AS NONE OF THE UNITS WERE USED, THERE WAS NO RESULTING INJURIES OR ADVERSE EVENTS ASSOCIATED WITH THE INCIDENT.

Additional Manufacturer Narrative

(B)(4). THE INCIDENT OCCURRED AS A RESULT OF OPERATOR ERROR. SUFFICIENT INSTRUCTIONS ARE PROVIDED IN THE COBAS AMPLISCREEN POOLING SYSTEM GUIDE ON HOW TO PROPERLY POSITION THE ARCHIVE PLATE FOR RESOLUTION TESTING AND FOR RE-ENTRY OF BARCODE INFORMATION. THERE IS NO RISK TO THE BLOOD SUPPLY IF THE INSTRUCTIONS PROVIDED ARE FOLLOWED. THERE WAS NO PRODUCT NONCONFORMANCE. (B)(4).