ASSY MAIN PRIMARY DRIVE DUAL

Additional Manufacturer Narrative

TROUBLESHOOTING WITH A BECKMAN CUSTOMER TECHNICAL SPECIALIST FOUND THE SAMPLE HAD BEEN REMOVED FROM THE DXA SYSTEM. NO ERRORS WERE REPORTED BY THE CENTRIFUGE OR TRANSPORT SYSTEM. THE SAMPLE SUCCESSFULLY PROCESSED WITH NORMAL RESULTS AFTER BEING RELOADED. BASED ON THE CURRENT INFORMATION, THERE'S INSUFFICIENT EVIDENCE OF A SYSTEM MALFUNCTION, AND THE PROBABLE CAUSE IS UNKNOWN. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED A ROUTING ISSUE ON THEIR DXA TRANSPORT SYSTEM CAUSED A PATIENT SAMPLE TO REMAIN IN THE ADAPTER SHUTTLE, DELAYING RESULTS. THIS WAS DISCOVERED WHEN RESULTS WERE REQUESTED. THE SAMPLE WAS MANUALLY FRONT-LOADED AND PROCESSED WITH NORMAL RESULTS. THIS DELAY IMPACTED PATIENT MANAGEMENT, SPECIFICALLY CAUSING A DELAY IN CHEMOTHERAPY TREATMENT, THOUGH THE PATIENT WAS NOT HARMED. NO FURTHER DETAILS WERE PROVIDED. THE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.