BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1070162 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05167
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS WHILE CRUSHING THE GLASS AMPULE OF THE COAGUCHEK CONTROL VIAL THE GLASS PROTRUDED FROM THE PLASTIC VIAL AND PUNCTURED THE FINGER. THE WOUND WAS CLEANED AND NO TREATMENT WAS RECEIVED. CUSTOMER WAS USING GAUZE AS DIRECTED IN LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIP CONTROL - NA JPA ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK