BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLTRACKS AUTOPREP SYSTEM

    MDR report key: 1427400 · Received April 30, 2009

    Report

    Report Number
    3004153557-2009-00002
    Event Type
    Malfunction
    Date Received
    April 30, 2009
    Date of Event
    April 3, 2009
    Report Date
    April 3, 2009
    Manufacturer
    VERIDEX LLC
    Product Code
    GKH
    PMA / PMN Number
    K040077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A SERVICE ORDER WAS COMPLETED BY THE FIELD ENGINEER ON 04/06/09. THE PROBLEM COULD NOT BE DUPLICATED AS THE CUSTOMER HAD ALREADY EDITED THE CARTRIDGE NUMBER. THE MAGNEST DATA BUTTON WHEN CHECKED AND TESTED WITH DIAGNOSTIC TEST PASSED ALL TESTS. THE INSTRUMENT WAS OPERATING AS EXPECTED AND REQUIRED NO REPAIRS. MAGNEST, CARTRIDGE AND LOG FILES WERE REQUESTED FOR FURTHER INVESTIGATION. AT THE TIME OF THIS ASSESSMENT THE ITEMS HAVE NOT BEEN RETURNED BY THE CUSTOMER. THE CUSTOMER WAS CONTACTED BY CUSTOMER TECHNICAL SUPPORT ON 4-21-09 REGARDING RETURN GOODS AUTHORIZATION STATUS. NO INFORMATION HAS BEEN RECEIVED TILL THIS DATE. USER GUIDE INFORMATION: THE CUSTOMER WAS USING A LINUX BASED SYSTEM. THE USER GUIDE/OPERATOR MANUAL FOR LINUX FOR THE CELLTRACKS ANALYZER II HAS A WARNING STATEMENT ON PAGE 8 STEP 2 THAT INDICATES THAT THE USER SHOULD VERIFY THE INFORMATION ABOUT THE SAMPLE AND TEST KIT THAT IS READ FROM THE DATA BUTTON. THIS STEP PREVENTS 'INCORRECT' INFORMATION FROM BEING REPORTED FOR A PARTICULAR PATIENT. HEALTH HAZARD ASSESSMENT: A MISREAD COULD RESULT IN THE SAMPLE ID FROM ONE PATIENT BEING ASSOCIATED WITH A DIFFERENT SAMPLE. THIS COULD LEAD TO POTENTIAL SAMPLE MIS-IDENTIFICATION AND MAY LEAD TO THE REPORTING OF ERRONEOUS TEST RESULT. IN THIS INSTANCE, NO ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN. THE CUSTOMER ANNOTATED THE RESULTS WITH THE CORRECT PATIENT IDENTIFICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED (ON (B)(6) 2009) THE CELLTRACKS ANALYZER II (B)(4) MISREAD THE CARTRIDGE ID ON ONE MAGNEST. CUSTOMER RAN THE SAMPLE ON CELLTRACKS AUTOPREP (B)(4) IN A BATCH OF 2 SAMPLES. SAMPLE 1 HAD A CARTRIDGE (B)(4) AND SAMPLE 2 HAD A CARTRIDGE ID OF (B)(4). WHEN THE CUSTOMER PLACED CARTRIDGE (B)(4) ON THE CELLTRACKS ANALYZER FIRST TO BE SCANNED, THE INSTRUMENT READ THE ID AS (B)(4). CUSTOMER READ THE MAGNEST 3 TIMES AND STILL IT READ THE ID AS (B)(4). THE ANALYZER WAS POWERED DOWN AND THEN BACK ON, BUT STILL THE CARTRIDGE ID WAS MISREAD. CUSTOMER PUT A NOTATION IN THE SCANNED RESULTS MENTIONING THE PATIENT ID WAS INCORRECT. VERIDEX CUSTOMER TECHNICAL SUPPORT (CTS) VERIFIED NO ERRONEOUS PATIENT RESULTS WAS RELEASED. THE CUSTOMER ANNOTATED THE RESULTS WITH THE CORRECT PATIENT IDENTIFICATION. MAGNEST, CARTRIDGE AND LOG FILES HAVE BEEN REQUESTED FROM THE CUSTOMER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLTRACKS AUTOPREP SYSTEM CELLTRACKS AUTOPREP SYSTEM GKH VERIDEX LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1