BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3840558 · Received May 30, 2014

    Report

    Report Number
    1823260-2014-03875
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 STATES THE PATIENT TESTED 3.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 1.7 INR. THE PATIENT'S COUMADIN DOSE WAS INCREASED BASED ON THE LAB RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM HOWEVER THE CALLER NO LONGER HAS THE TEST STRIPS; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319039 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 033 MO ASPIRIN| COUMADIN