BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3821717 · Received May 20, 2014

    Report

    Report Number
    1823260-2014-03569
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 2, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    CALLER TESTED 2.5 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 1.88 INR. PATIENT'S WARFARIN DOSE WAS INCREASED BASED ON THE LAB RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, CALLER NO LONGER HAS THE SUSPECT STRIP VIAL TO RETURN. REPLACEMENTS WERE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298471 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22222111

    Patients

    Seq Age Sex Outcome Treatment
    1 022 YR WARFARIN