CELLSEARCH CIRCULATING TUMOR CELL KIT

Report

Report Number: 3004582358-2008-00003
Event Type: Malfunction
Date Received: June 16, 2008
Date of Event: May 14, 2008
Report Date: May 21, 2008
Manufacturer: VERIDEX LLC
Product Code: NQI
PMA / PMN Number: K073338
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CELLSEARCH CIRCULATING TUMOR CELL KIT	CELLSEARCH CTC KIT	NQI	VERIDEX LLC	NA	0107

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA