BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3111987 · Received May 14, 2013

    Report

    Report Number
    1823260-2013-02936
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 28, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/LABORATORY RESULTS WERE OBTAINED: 3.3 INR/2.4 INR; 4.1 INR/2.9 INR; 3.3 INR/2.34 INR; 3.8 INR/2.74 INR; 4.2 INR/3.19 INR; 4.8 INR/3.59 INR; 3.0 INR/2.18 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM HOWEVER CALLER NO LONGER HAS THE TEST STRIPS; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213299 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21625211

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN