BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1336903 · Received March 10, 2009

    Report

    Report Number
    1823260-2007-05095
    Event Type
    Malfunction
    Date Received
    March 10, 2009
    Date of Event
    May 10, 2007
    Report Date
    June 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT 2: FEMALE, ATRIAL FIBRILLATION. MEDICATION UNK. NO ACTION TAKEN ON RESULT. NO ADVERSE EVENT REPORTED. PATIENT 3: FEMALE, MEDICATION UNK. COUMADIN WAS HELD FOR 2 DAYS, NO ADVERSE EVENT REPORTED. PATIENT 4: NO INFORMATION PROVIDED.

    Description of Event or Problem · 1

    CALLER STATES THAT DURING A CORRELATION STUDY, THE FOLLOWING COAGUCHEK SYSTEM 1/LAB RESULTS WERE OBTAINED: PATIENT 1: 4.8 INR/3.5 INR AND 8.0 INR/5.5 INR; PATIENT 2: 4.5 INR/3.3 INR AND 5.2 INR/3.5 INR; PATIENT 3: 7.0 INR/5.2 INR; PATIENT 4: 3.8 INR/2.9 INR. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIP JPA ROCHE DIAGNOSTICS 525A-B17

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR