BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1022321 · Received March 27, 2008

    Report

    Report Number
    1823260-2008-02800
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE IN THE COAGUCHEK S SYSTEM. REFERENCE MEDWATCH WITH A1 PATIENT FOR SUSPECT DEVICE IN THE COAGUCHEK XS SYSTEM. NO PATIENT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    CALLER REPORTS DURING A STUDY, THE FOLLOWING COAGUCHEK XS/COAGUCHEK S RESULTS WERE OBTAINED: 3.4 INR/2.6 INR. 3.5 INR/2.6 INR. DURING THE SAME STUDY, THE FOLLOWING COAGUCHEK S/LABORATORY RESULTS WERE OBTAINED: 2.2 INR/1.6 INR. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS - JPA JPA ROCHE DIAGNOSTICS 639A--C7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK