BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT CHECK QUALITY CONTROL

    MDR report key: 2551325 · Received April 23, 2012

    Report

    Report Number
    2250033-2012-00004
    Event Type
    Malfunction
    Date Received
    April 23, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 26, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ACTUAL DEVICE NOT EVALUATED. A CAPA WAS COMPLETED FOR DIRECTCHECK STARTING WITH LOTS MANUFACTURED IN JUNE 2011. EACH DIRECTCHECK PACKAGE INCLUDES AN INSERT CONTAINING A PICTURE DEMONSTRATING THE PREFERRED TECHNIQUE TO USE DURING ACTIVATION OF THE DIRECTCHECK ASSEMBLY. IN ADDITION, THE ITC WEBSITE INCLUDES A VIDEO WHICH ILLUSTRATES THE PREFERRED TECHNIQUE TO USE DURING ACTIVATION OF THE DIRECTCHECK ASSEMBLY. NO PRODUCT RETURNED. RESULT: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: HUMAN FACTORS ISSUE. THE DIRECTCHECK PROTECTIVE SLEEVE IS PROVIDED AS A MEANS TO REDUCE PROBABILITY OF CUTS. THE INSTRUCTIONS FOR USE INDICATES USE OF PROTECTIVE SLEEVE IS REQUIRED WHEN CONTROL VIALS ARE ACTIVATED.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTS THAT END USER'S SKIN WAS PUNCTURED FROM PIECE OF GLASS WHEN ACTIVATING THE DIRECT CHECK QUALITY CONTROL. CUSTOMER WAS NOT USING PROTECTIVE SLEEVE AT THE TIME OF THE INCIDENT. NO REPORT OF SERIOUS INJURY, OR ADMINISTRATION OF MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT CHECK QUALITY CONTROL GGN INTERNATIONAL TECHNIDYNE CORP. DCJACT-A M1DCA027

    Patients

    Seq Age Sex Outcome Treatment
    1