BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 2241724 · Received September 9, 2011

    Report

    Report Number
    1823260-2011-04815
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 13, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER TESTED 7.0 INR AND 3.4 INR ON THE COAGUCHEK XS SYSTEM. CALLER STATES SHE HAD DOUBLE-DOSED THE TEST STRIP WHEN THE RESULT OF 7.0 INR WAS OBTAINED. NO TREATMENT INFORMATION PROVIDED. 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® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20306224

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR NEURONTIN| PRAVASTATIN| LEVOXYL| COUMADIN| SOTALOL| VITAMIN D