BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM CHECK COAG WHOLE BLOOD CONTROL

    MDR report key: 3636672 · Received December 19, 2013

    Report

    Report Number
    1217183-2013-00017
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    November 20, 2013
    Report Date
    November 22, 2013
    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

    THE GEM CHECK COAG CONTROL IS MANUFACTURED FOR INSTRUMENTATION LABORATORY COMPANY BY (B)(4). (B)(4) HAS SUBMITTED MDR #2250033-2013-00008 TO DOCUMENT THIS INCIDENT. ACTUAL DEVICE WAS RETURNED TO (B)(4), BUT NOT EVALUATED BY INSTRUMENTATION LABORATORY CO. U.S. PICTURES WERE OBTAINED SHOWING THE CRACK IN THE VIAL. THE END USER WAS NOT USING THE PROTECTIVE SLEEVE AT THE TIME OF THE INJURY AND CONTROL MATERIAL WAS EXPIRED. CUSTOMER STATED THAT THEY WERE AWARE THE CONTROL HAD EXPIRED, BUT USED IT ANYWAY. THE 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 AND WHILE DISPENSING THE CONTROL MATERIAL. EACH PACKAGE INCLUDES AN INSERT CONTAINING A PICTURE DEMONSTRATING THE PREFERRED TECHNIQUE TO USE DURING ACTIVATION OF THE VIAL.

    Description of Event or Problem · 1

    HEALTHCARE FACILITY REPORTS END USER WAS INJURED WHEN USING GEM CHECK COAG WHOLE BLOOD CONTROL. LAB ASSISTANT SUSTAINED A SMALL CUT ON HER FINGER FROM A PIECE OF GLASS THAT PIERCED THROUGH THE CONTROL VIAL. THE END USER CONFIRMED THE PROTECTIVE SLEEVE WAS USED DURING THE CRUSHING PROCESS TO ACTIVATE THE CONTROL MATERIAL AND SHE WORE GLOVES AT ALL TIMES. AFTER ACTIVATING THE CONTROL, SHE SUBSEQUENTLY REMOVED THE VIAL FROM THE PROTECTIVE SLEEVE AND HELD THE VIAL TO DISPENSE THE CONTROL MATERIAL. THE END USER FELT A STICK ON HER FINGER, AND NOTICED MINOR BLEEDING ONCE REMOVING HER GLOVE. THE LAB ASSISTANT WAS IMMEDIATELY EVALUATED BY THE HOSPITAL PHYSICIAN AND THE MATERIAL SAFETY DATA SHEET WAS PROVIDED. NO REPORT OF SERIOUS INJURY. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667972 GEM CHECK COAG WHOLE BLOOD CONTROL GGN INTERNATIONAL TECHNIDYNE CORPORATION M1GP3003

    Patients

    Seq Age Sex Outcome Treatment
    1