BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 2990798 · Received March 5, 2013

    Report

    Report Number
    1823260-2013-01322
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 7, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 0.94 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 8.4 INR. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92851 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21417211

    Patients

    Seq Age Sex Outcome Treatment
    1 008 YR MARIVARIN| UNK ANTIBIOTICS