BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3173519 · Received June 17, 2013

    Report

    Report Number
    1823260-2013-03633
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR THE SUSPECT PRODUCT USED WITH COAGUCHEK XS SYSTEM 1. SEE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT PRODUCT WITH COAGUCHEK XS SYSTEM 2. IT IS NOT KNOWN IF THE INITIAL REPORTER HAS OR INTENDS TO REPORT THE EVENT TO FDA.

    Description of Event or Problem · 1

    REPORTER STATED THAT A PATIENT CAPILLARY SAMPLE WAS TESTED ON COAGUCHEK XS SYSTEM 1 WHICH REPORTED A RESULT OF 1.6 INR. ONE HOUR AND 15 MINUTES LATER, AND ADDITIONAL CAPILLARY SAMPLE OBTAINED FROM THE SAME PATIENT, MEASURED 2.5 INR ON COAGUCHEK XS SYSTEM 2. NO ACTION BASED ON THE DEVICE RESULTS WAS REPORTED AND NO ADVERSE EVENT OCCURRED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274193 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21815511

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR CELEBREX| GLIPIZIDE| VITAMIN B12| LISINOPRIL| AMOLODIPINE| TERAZOSIN| FERROUS SULFATE| MULTIVIAMIN| COUMADIN| IMMODIUM| LASIX| FINASTERIDE| PROTONIX| METOPROLOL