BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1771968 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08156
    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

    Description of Event or Problem · 1

    CALLER STATES DURING A CORRELATION STUDY, THE FOLLOWING COAGUCHEK S/LAB VALUES WERE OBTAINED: PATIENT 1: 4.9 INR/3.1 INR; PATIENT 2: 2.9 INR/2.2 INR; PATIENT 4: 5.0 INR/2.9 INR; PATIENT 7: 4.6 INR/3.0 INR. LAB RESULTS WERE USED TO MAKE TREATMENT DECISIONS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 2

    CALLER STATES DURING A CORRELATION STUDY, THE FOLLOWING COAGUCHEK S/LAB VALUES WERE OBTAINED: PATIENT 3: 3.8 INR/2.8 INR. LAB RESULTS WERE USED TO MAKE TREATMENT DECISIONS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 3

    CALLER STATES DURING A CORRELATION STUDY, THE FOLLOWING COAGUCHEK S/LAB VALUES WERE OBTAINED: PATIENT 5: 2.7 INR/1.9 INR; >8.0 INR/5.3 INR. LAB RESULTS WERE USED TO MAKE TREATMENT DECISIONS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 4

    CALLER STATES DURING A CORRELATION STUDY, THE FOLLOWING COAGUCHEK S/LAB VALUES WERE OBTAINED: PATIENT 6: 5.3 INR/3.4 INR; >8.0 INR/5.3 INR. LAB RESULTS WERE USED TO MAKE 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 563A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA
    2 35 YR COUMADIN
    3 35 YR COUMADIN
    4 NA COUMADIN