BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT CHECK QUALITY CONTROL

    MDR report key: 2193024 · Received July 21, 2011

    Report

    Report Number
    2250033-2011-00019
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 29, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DEVICE HISTORY RECORD REVIEWED FOR NCMR. NO PRODUCT RETURNED. RESULT: RECORD EVALUATION COMPLETED. PRODUCT MET ALL RELEASE CRITERIA. CONCLUSION: USER ERROR MAY HAVE CONTRIBUTED TO ALLEGED EVENT. CUSTOMER COULD NOT IDENTIFY WHICH OF THE TWO LOTS (B)(4) WERE USED. 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

    PATIENT 1 OF 2. HEALTHCARE PROFESSIONAL REPORTS THAT A USER RECEIVED A CUT WHILE USING DIRECT CHECK QUALITY CONTROL. THE USER WAS NOT USING THE PROTECTIVE SLEEVE AT THE TIME OF THE INCIDENT. CUSTOMER PROVIDED TRAINING TO EMPLOYEE ON USE OF PROTECTIVE SLEEVE. ITC PROVIDED INFO PERTAINING TO THE COMPOSITION OF THE MATERIALS. NO REPORT OF SERIOUS INJURY. UNSPECIFIED TREATMENT WAS PROVIDED. MEDICAL SAFETY DATA SHEET WAS PROVIDED TO CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT CHECK QUALITY CONTROL GGN INTERNATIONAL TECHNIDYNE CORPORATION DCJLR-A J0DLA040

    Patients

    Seq Age Sex Outcome Treatment
    1