BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3142876 · Received June 3, 2013

    Report

    Report Number
    1823260-2013-03316
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 3, 2013
    Report Date
    September 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 21637411, EXPIRATION DATE 03/31/2014). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED >8.0 INR ON COAGUCHEK XS SYSTEM 1, AND >8.0 INR ON COAGUCHEK XS SYSTEM 2 WHILE A COMPARISON LAB RETURNED AS 5.0 INR. PATIENT'S COUMADIN WAS HELD BASED ON THE DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243392 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21637411

    Patients

    Seq Age Sex Outcome Treatment
    1 085 YR COUMADIN DAILY| DIFLUCAN| NYSTATIN ONCE DAILY