BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECTCHECK QUALITY CONTROL

    MDR report key: 3856474 · Received April 22, 2014

    Report

    Report Number
    2250033-2014-00003
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Report Date
    March 27, 2014
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION - HUMAN FACTORS ISSUE. END USER WAS NOT USING THE PROTECTIVE SLEEVE AT THE TIME OF THE INJURY. 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. EACH PACKAGE INCLUDES AN INSERT CONTAINING A PICTURE DEMONSTRATING THE PREFERRED TECHNIQUE TO USE DURING ACTIVATION OF THE ASSEMBLY. IN ADDITION, THE ITC WEBSITE INCLUDES A VIDEO WHICH ILLUSTRATES THE PREFERRED TECHNIQUE TO USE DURING ACTIVATION.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS THAT AN END USER WAS CUT ON THE TOP OF HER LEFT THUMB WHEN SQUEEZING THE DIRECT CHECK QUALITY CONTROL VIAL. THE USER WAS NOT USING THE PROVIDED PROTECTIVE SLEEVE AT THE TIME OF THE INCIDENT. THE AFFECTED AREA WAS DISINFECTED. INITIAL BLOOD TEST RESULTS FOR HIV AND HCV WERE NEGATIVE. THERE WAS NO REPORT OF SERIOUS INJURY. DURING FOLLOW UP COMMUNICATIONS, THE CUSTOMER REPORTED THAT THE LAB ASSISTANT'S FINGER HEALED NICELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243809 DIRECTCHECK QUALITY CONTROL PLASMA, COAGULATION CONTROL GGN INTERNATIONAL TECHNIDYNE CORPORATION K3DNC011

    Patients

    Seq Age Sex Outcome Treatment
    1