BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® S SYSTEM

    MDR report key: 2130794 · Received June 16, 2011

    Report

    Report Number
    1823260-2011-03308
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 8, 2011
    Report Date
    July 29, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 7.5 INR ON THE COAGUCHEK S SYSTEM AND 3.59 INR ON A COMPARISON LAB. CALLER STATES THE COUMADIN WAS HELD FOR THE PATIENT DAYS AND THEN DECREASED. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK ® S SYSTEM PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS NA 959A

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR COUMADIN