BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1780652 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08433
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR A SUSPECT DEVICE IN COAGUCHEK S SYSTEM. REFERENCE MEDWATCH WITH (B)(4) FOR SUSPECT DEVICE IN COAGUCHEK XS SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTS THE PT TESTED 3.5 INR ON THE COAGUCHEK XS SYSTEM AND 4.6 INR ON THE COAGUCHEK S SYSTEM DURING DUPLICATE TESTING. NO TREATMENT INFO PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS - JPA JPA ROCHE DIAGNOSTICS 586A H9

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MEDICATIONS UNK