BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3800915 · Received May 8, 2014

    Report

    Report Number
    1823260-2014-03339
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 15, 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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER TESTED >8.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 5.9 INR. NO TREATMENT REQUIRED. COUMADIN HAD BEEN PLANNED TO BE HELD STARTING THE DAY OF THE TESTS DUE TO AN UPCOMING SCHEDULED PROCEDURE TO REPLACE HIS ICD DEFIBRILLATOR. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277180 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22222111

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR COUMADIN| CARVEDILOL| LISINOPRIL| ICD DEFIBRILLATOR| LOVASTATIN| FUROSEMIDE| SPIRONOLACTONE| AMIODARONE