BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5790233 · Received July 13, 2016

    Report

    Report Number
    1823260-2016-00910
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    June 29, 2016
    Report Date
    August 3, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN THE STRIPS. A SPECIFIC ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED AS THE SUSPECT PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE RETURNED METER AND REFERENCE METER WERE TESTED WITH THE CURRENT MASTERLOT OF STRIPS. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RETURNED METER AND THE RETENTION METER MEET THE SPECIFICATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446653 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 23343321

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR