THERASEED PD-103

Additional Manufacturer Narrative

UPON REVIEW OF THE ORDER FORM, IT WAS CONFIRMED THAT THE UNITS OF ACTIVITY ORDERED BY THE CUSTOMER WAS ENTERED INCORRECTLY DURING THE ORDER ENTRY PROCESS. THE CUSTOMER REQUESTED 1.7 MCI AND THE ORDER WAS ENTERED AS 1.7 U. THE CUSTOMER SERVICE REPRESENTATIVE DID NOT CONFIRM THE ORDER ACTIVITY WITH THE CUSTOMER PRIOR TO ENTRY. THE ACTIVITY WAS ENTERED LOWER THAN REQUESTED BY THE CUSTOMER. THE ERROR WAS NOT DETECTED DURING THE ORDER ENTRY VERIFICATION PROCESS PRIOR TO SHIPMENT OF THE ORDER NOR DURING THE CUSTOMER'S ORDER CONFIRMATION PROCESS. UPON QUALITY REVIEW OF THE RECEIVED ORDER AT THE USERS FACILITY, THE DISCREPANCY WAS DETECTED, AND THE PLANNED TREATMENT WAS CANCELLED. THERE WAS NO FAILURE OR MALFUNCTION. THE SEED ORDER WAS FILLED WITH A LOWER THAN REQUESTED ACTIVITY, WHICH WOULD HAVE RESULTED IN A MISADMINISTRATION.

Description of Event or Problem

SEED ACTIVITY FOR BRACHYTHERAPY ORDER WAS ENTERED USING THE WRONG UNITS CAUSING A DISCREPANCY BETWEEN THE ORDERED SEED STRENGTH AND THE SEED STRENGTH THAT WAS DELIVERED. THE ERROR WAS DETECTED AT THE USER FACILITY PRIOR TO USE AND THE TREATMENT PLAN AND ORDER WAS CANCELLED.