BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7801571 · Received August 21, 2018

    Report

    Report Number
    1823260-2018-02799
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    July 17, 2018
    Report Date
    August 21, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702127104
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION - THE OCCUPATION IS LAY USER/PATIENT. DEVICE WAS REQUESTED FOR RETURN BUT WAS NOT AVAILABLE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644667 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 250322 00365702127104

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR