BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® S SYSTEM

    MDR report key: 2191960 · Received August 4, 2011

    Report

    Report Number
    1823260-2011-04206
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 25, 2011
    Report Date
    September 12, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    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 PATIENT TESTED >8.0 INR AND >8.0 INR ON THE COAGUCHEK S SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.9 INR. NO ACTIONS TAKEN BASED ON 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
    1 COAGUCHEK ® S SYSTEM PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS NA 964A

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR COUMADIN DAILY