BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2802754 · Received October 24, 2012

    Report

    Report Number
    1823260-2012-05348
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 1 (LOT NUMBER 21333312, EXPIRATION DATE 09/30/2013). REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A (B)(6) STUDY, THE FOLLOWING COAGUCHEK XS 1/COAGUCHEK XS 2 RESULTS WERE OBTAINED: 1) 4.8 INR/2.0 INR 2) 2.3 INR/1.6 INR 3) 3.9 INR/2.2 INR 4) 6.6 INR/3.1 INR 5) 5.4 INR/3.0 INR 6) 4.5 INR/2.2 INR 7) 7.1 INR/2.6 INR 8) 6.2 INR/3.6 INR 9) 3.4 INR/1.8 INR NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE 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 21333312

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN