BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 4256118 · Received November 17, 2014

    Report

    Report Number
    1823260-2014-08964
    Event Type
    Malfunction
    Date Received
    November 17, 2014
    Date of Event
    October 21, 2014
    Report Date
    January 9, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    REPORTER STATES PATIENT TESTED >8.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.8 INR. PATIENT WAS GIVEN AN UNSPECIFIED DOSE OF VITAMIN K TO TAKE WHEN SHE GOT HOME AND WAS ADVISED TO HOLD HER COUMADIN PRIOR TO THE LAB RESULT COMING BACK. WHEN THE LAB RESULT WAS RETURNED, THE PATIENT WAS INSTRUCTED TO RESUME HER COUMADIN DOSE AS NORMAL. NO ADVERSE EVENT DUE TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741898 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22737011

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR COUMADIN