BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT CHECK QUALITY CONTROL

    MDR report key: 2501230 · Received March 16, 2012

    Report

    Report Number
    2250033-2012-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    January 1, 2012
    Report Date
    February 21, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER DID NOT KNOW THE LOT# OF THE DIRECTCHECK QUALITY CONTROL INVOLVED. (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. 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 THAT A NURSE STUCK HERSELF WITH A DIRECT CHECK QUALITY CONTROL. NURSE RECEIVED INJURY TO LEFT HAND, SECOND DIGIT. UNCERTAIN IF USER WAS 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. DCJLR-N

    Patients

    Seq Age Sex Outcome Treatment
    1