BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3790672 · Received May 5, 2014

    Report

    Report Number
    1823260-2014-03187
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 28, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 5.1 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.1 INR. CALLER DOES NOT KNOW IF THE PATIENT'S MEDICATIONS WERE ALTERED OR IF PATIENT HAD TO RECEIVE TREATMENT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER THE TEST STRIPS ARE NO LONGER AVAILABLE; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268558 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22208011

    Patients

    Seq Age Sex Outcome Treatment
    1