BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1710449 · Received June 4, 2010

    Report

    Report Number
    1823260-2010-03364
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 27, 2010
    Report Date
    July 8, 2010
    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

    A PHYSICIAN'S OFFICE REPORTED THAT COMPARISON TESTS WERE PERFORMED USING CONTOUR AND A COMPETITOR'S METER. THE CONTOUR READ IN THE 101-108 MG/DL RANGE, WHILE THE OTHER METER READ IN THE 200 MG/DL RANGE. DEPENDING ON THE READINGS OF THE COMPETITOR'S METER, THE DIFFERENCE COULD FALL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. NO OTHER INFO WAS PROVIDED ABOUT THIS EVENT.

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 7.4 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 4.6 INR. PATIENT'S COUMADIN DOSE WAS HELD FOR 2 DAYS BASED ON METER AND LAB VALUES. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20179331

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR CARDIZEM| DIOVAN HCT| LIPITOR| COUMADIN DAILY