BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 843146 · Received February 26, 2007

    Report

    Report Number
    1823260-2007-01641
    Event Type
    Malfunction
    Date Received
    February 26, 2007
    Date of Event
    February 13, 2007
    Report Date
    February 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    k930454
    Removal / Correction Number
    Z-0098-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE IS COAGUCHEK TEST STRIP CONTROL.

    Description of Event or Problem · 1

    CALLER STATES THAT SHE CUT HER FINGER WHILE RUNNING ROUTINE CONTROLS. SHE STATES THAT SHE WRAPPED THE CONTROL VIAL WITH A SOFT CLOTH, BUT STILL CUT HER FINGER ON GLASS THAT PROTRUDED FROM VIAL. CALLER SELF TREATED WITH ANTIBACTERIAL SOAP, ALCOHOL, AND A BAND-AID. DEVICE: COAGUCHEK S LOW VOLUME CONTROLS, CAT/3033384.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST SYSTEM - JPA JPA ROCHE DIAGNOSTICS * 162089

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR