BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2191963 · Received August 4, 2011

    Report

    Report Number
    1823260-2011-04207
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 7.6 INR AND 8.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 13.0 INR. PATIENT WAS TREATED WITH VITAMIN K BASED ON LAB VALUE. 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 20314711

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR BYSTOLIC DAILY| UNKNOWN CHEMOTHERAPY| POTASSIUM| LASIX| CARDIZEM| NEXIUM DAILY| WARFARIN