BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3080611 · Received April 26, 2013

    Report

    Report Number
    1823260-2013-02578
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    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 3.6 INR AND 3.6 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.7 INR. CALLER HELD HER COUMADIN DOSE BASED ON THE METER RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181334 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21625121

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR OXYCODONE| EFFEXOR| NEXIUM| METFORMIN| DIAZEPAM| PRENATAL VITAMINS| COUMADIN| FENTANYL