BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECTCHECK QUALITY CONTROL

    MDR report key: 2622679 · Received June 18, 2012

    Report

    Report Number
    2250033-2012-00006
    Event Type
    Malfunction
    Date Received
    June 18, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 25, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED (B)(4) 2012. CUSTOMER DID NOT KNOW THE LOT # OF THE DIRECTCHECK QUALITY CONTROL INVOLVED. METHOD CODE: 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 CODE: NO RESULT AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION CODE: 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. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS END USER WAS INJURED ON HER FINGER FROM PIECE OF GLASS WHEN RUNNING THE DIRECTCHECK QUALITY CONTROL. END USER WAS NOT USING THE PROTECTIVE SLEEVE AT THE TIME OF THE INCIDENT. NO REPORT OF SERIOUS INJURY OR ADMINISTRATION OF MEDICAL TREATMENT. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES DURING THE COURSE OF A PHARMACEUTICAL CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECTCHECK QUALITY CONTROL GGN INTERNATIONAL TECHNIDYNE CORP. DCJLR-N

    Patients

    Seq Age Sex Outcome Treatment
    1