CELLSEARCH CIRCULATING TUMOR CELL KIT

Description of Event or Problem

CUSTOMER REPORTING AN EVENT OF DISCREPANT RESULTS OBTAINED FROM 2 SCANS OF THE SAME SAMPLE TO THE KIT LOT# 0107 BY THE CELL TRACKS ANALYZER. CUSTOMER INDICATES THAT THE DESCRIBED EVENT OCCURRED IN '08. THE SAMPLE WAS SCANNED IN CARTRIDGE NO: 361476. CUSTOMER REPORTING THE FIRST SCAN TO BE OF 1126 UNASSIGNED EVENTS WITH 302 CTC'S. THE SECOND SCAN YIELDED 1067 UNASSIGNED EVENTS WITH 238 CTC'S. CUSTOMER DID NOT DISCLOSE AS TO WHY THE SAMPLE WAS SCANNED. THE CUSTOMER INDICATES THAT THE SPECIMEN WAS SCANNED BECAUSE OF THE CONCERN OF THE HIGH NUMBER OF CTC'S. CTS DID CONFIRM THAT THE SECOND SCAN WITH THE CTC COUNT OF 238 WAS REPORTED.

Additional Manufacturer Narrative

CUSTOMER REPORTED THE INCIDENT FOR DOCUMENTATION ONLY, AND DOES NOT REQUEST ADDITIONAL INVESTIGATION BY VERIDEX. AN RGA WAS ISSUED BY CTS, BUT RETURNED MATERIAL WAS NOT RECEIVED FROM THE CUSTOMER. NO SERVICE ACTIVITY PERFORMED. EVENT NOT BE INVESTIGATED FURTHER AT THIS TIME. CUSTOMER INDICATES THAT THE CARTRIDGE IS AVAILABLE, BUT DOES NOT WISH FOR ANY ADDITIONAL INVESTIGATION BY VERIDEX AS A RESULT OF THE CARTRIDGE BEING SO OLD. CUSTOMER ONLY REPORTING THE EVENT FOR DOCUMENTATION OF THE CONCERN. CTS ADVISED THE CUSTOMER THAT THE CONCERN/EVENT WOULD BE DOCUMENTED. THE CUSTOMER HAS AGREED TO CONTACT CTS IN THE EVENT THAT A SIMILAR CONCERN ARISES. NO FURTHER ACTION INDICATES BY CTS.