BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3170307 · Received June 14, 2013

    Report

    Report Number
    1823260-2013-03598
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 14, 2013
    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
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE INITIAL REPORTER HAS OR INTENDS TO REPORT THE EVENT TO FDA. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT TESTED ON THE COAGUCHEK XS SYSTEM (CAPILLARY SAMPLE) WITH A RESULT OF 5.0 INR. TWO HOURS LATER, PATIENT WAS TESTED ON AN UNSPECIFIED LABORATORY INSTRUMENT (SAMPLE TYPE NOT REPORTED) WHICH REPORTED A RESULT OF 3.0 INR. PATIENT DID NOT MODIFY THERAPY BASED ON THE COAGUCHEK XS RESULT AND NO ADVERSE EVENT OCCURRED. THE SUSPECT PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270251 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 084 YR TYLENOL| CELEBREX| ASPIRIN| WARFARIN