BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLSEARCH CIRCULATING TUMOR CELL KIT

    MDR report key: 1051758 · Received May 19, 2008

    Report

    Report Number
    3004582358-2008-00002
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 16, 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

    TWO CD LOG FILES OF THE RESULT WERE RETURNED BY THE CUSTOMER TO VERIDEX FOR TECHNICAL REVIEW. ON-SITE VISIT BY VERIDEX REPRESENTATIVE WAS CONDUCTED. NO DEFINITIVE ROOT CAUSE WAS DETERMINED FOR REPORTED DISCREPANT RESULTS (79 CTC AND 4 CTC). THE SYSTEM LOGS PROVIDED BY THE CUSTOMER WERE REVIEWED BY A VERIDEX SPECIALIST AND CONFIRMED THE CTCS OF 79 AND 4 RESPECTIVELY AS IDENTIFIED BY THE CUSTOMER. DURING ON SITE VISIT CONDUCTED BY VERIDEX, SAMPLE PREPARATION AND ANALYSIS WAS OBSERVED. THE OBSERVATION INDICATED THAT THE PROCEDURE BEING USED BY THE CUSTOMER WAS NOT IN ACCORDANCE WITH THE USER TRAINING WITH RESPECT TO SAMPLE SEPARATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TWO SAMPLES DRAWN FROM THE SAME PT ON (B) (6) 2008 (AROUND 11AM PST) GENERATED RESULTS OF 79 CIRCULATING TUMOR CELLS (CTC) AND 4 CTC. THE FIRST TEST WAS CONDUCTED THE EVENING OF (B) (6) 2008 USING CTC KIT LOT 0087. THE SECOND TEST WAS CONDUCTED ON (B) (6) 2008 ALSO USING CTC KIT LOT 0087. A CONTROL WAS INCLUDED WITH BOTH TESTS. BLOOD WAS COLLECTED IN THE CELLSAVE TUBE AND STORED AT ROOM TEMPERATURE, (CELLSAVE TUBE LOT NUMBER 725806). NO AGGREGATION WAS OBSERVED. NO OTHER SAMPLES WERE TESTED ON EITHER DAY. THE WASH BUFFER WAS STORED WITH THE KIT IN THE FRIDGE AFTER EACH USE. CONTROLS PASSED. CUSTOMER STATES THAT DAILY CLEANING IS PERFORMED ON THE AUTOPREP. CUSTOMER INDICATED THAT THE 4 CTC CELL COUNT WAS REPORTED. INSTRUMENTS USED WERE AUTOPREP (B) (4) AND CELLTRACKS ANALYZER (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLSEARCH CIRCULATING TUMOR CELL KIT CELLSEARCH CTC KIT NQI VERIDEX, LLC NA 0087

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT AVAILABLE