BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1243230 · Received November 7, 2008

    Report

    Report Number
    1823260-2008-08237
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 1.4 INR, 1.7 INR, 2.2 INR, AND 2.4 INR ON THE COAGUCHEK S SYSTEM DURING DUPLICATE TESTING. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS-JPA JPA ROCHE DIAGNOSTICS 702A-D12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK