BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1780136 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08305
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 1, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK XS SYSTEM. (B)(4). NO PATIENT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    CALLER STATES DURING A CORRELATION STUDY, THE FOLLOWING COAGUCHEK S/COAGUCHEK XS RESULTS WERE OBTAINED: PATIENT 1: 1.4 INR/2.0 INR. PATIENT 2: 1.6 INR/2.2 INR. PATIENT 3: 3.0 INR/4.0 INR. PATIENT 4: 2.6 INR/3.4 INR. PATIENT 5: 1.7 INR/2.3 INR. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIP - GJS GJS ROCHE DIAGNOSTICS 20152731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA