BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1772013 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08155
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    July 26, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO PROVIDED FOR PATIENTS 1, 3, 4, AND 6.

    Description of Event or Problem · 1

    CALLER STATES DURING A CORRELATION STUDY, THE FOLLOWING COAGUCHEK S/LAB RESULTS WERE OBTAINED: PT 1: 4.9 INR/3.1 INR, PT 3: 4.1 INR/3.1 INR, PT 4: >8.0 INR/5.2 INR, PT 6: 2.4 INR/1.8 INR. LAB RESULTS WERE USED FOR TREATMENT DECISIONS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Additional Manufacturer Narrative · 2

    NO PT INFO PROVIDED FOR PATIENTS 1, 3, 4, AND 6.

    Description of Event or Problem · 2

    CALLER STATES DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK S/LAB RESULTS WERE OBTAINED: 3.9 INR/2.8 INR. LAB RESULTS WERE USED FOR TREATMENT DECISIONS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Additional Manufacturer Narrative · 3

    NO PATIENT INFORMATION PROVIDED FOR PATIENTS 1, 3, 4, AND 6.

    Description of Event or Problem · 3

    CALLER STATES DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK S/LAB RESULTS WERE OBTAINED: 3.4 INR/2.5 INR. LAB RESULTS WERE USED FOR TREATMENT DECISIONS. 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 STRIP ¿ JPA JPA ROCHE DIAGNOSTICS 571A-F12

    Patients

    Seq Age Sex Outcome Treatment
    1 NA
    2 35 YR COUMADIN 5MG/5MG/2.5MG 3 DAY CYCLE
    3 NA COUMADIN