BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 3896256 · Received June 26, 2014

    Report

    Report Number
    1823260-2014-04698
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). DEVICE STRIPS NOT RETURNED.

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 6.5 INR AND 4.4 INR ON THE COAGUCHEK XS PLUS SYSTEM. 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
    374592 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 223861

    Patients

    Seq Age Sex Outcome Treatment
    1 085 YR UNKNOWN ANTIBIOTICS