BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2761051 · Received September 26, 2012

    Report

    Report Number
    1823260-2012-04855
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT TESTED A CAPILLARY SAMPLE, ON THE COAGUCHEK XS SYSTEM, AND OBTAINED A RESULT OF 2.3 INR. WITHIN AN HOUR, A VENOUS SAMPLE OBTAINED FROM THE PATIENT REPORTEDLY MEASURED 1.8 INR ON A LABORATORY INSTRUMENT. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20968311

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR MEDYN FORTE| AMLODIPINE| MEVALOTIN| CARVEDILOL| PENTALONG| MARCUMAR| PROVAS