BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2864597 · Received December 10, 2012

    Report

    Report Number
    1823260-2012-06215
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 1.9 INR AND 3.9 INR ON THE COAGUCHEK XS SYSTEM. CALLER STATES HER FINGER BLED FOR SEVERAL MINUTES AFTER TESTING 1.9 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE 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 21432623

    Patients

    Seq Age Sex Outcome Treatment
    1 027 YR MACROBID| TOPIRAMATE| TYLENOL #3| ADDERALL| WARFARIN