BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1771967 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08149
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    August 9, 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK S SYSTEM. REFERENCE MEDWATCH WITH (B)(4) FOR SUSPECT DEVICE IN COAGUCHEK XS SYSTEM. NO PATIENT INFORMATION PROVIDED FOR ADDITIONAL PATIENTS.

    Description of Event or Problem · 1

    CALLER STATES DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK S / COAGUCHEK XS RESULTS WERE OBTAINED: PATIENT 1 - 2.1 INR/2.9 INR, PATIENT 2 - 2.1 INR/2.9 INR, PATIENT 3 - 2.0 INR/2.5 INR, PATIENT 4 - 2.1 INR/2.9 INR, PATIENT 5 - 1.5 INR/2.0 INR, PATIENT 6 - 2.9 INR/4.0 INR, PATIENT 7 - 2.3 INR/3.3 INR, PATIENT 8 - 1.7 INR/2.5 INR, PATIENT 9 - 1.7 INR/2.6 INR, PATIENT 10 - 2.0 INR/2.5 INR, PATIENT 11 - 1.8 INR/2.5 INR, PATIENT 12 - 1.2 INR/1.7 INR, PATIENT 13 - 2.0 INR/2.7 INR, PATIENT 14 - 2.9 INR/4.0 INR, PATIENT 15 - 1.9 INR/2.4 INR, PATIENT 16 - 2.8 INR/3.9 INR, PATIENT 17 - 2.0 INR/2.6 INR. NO ACTION TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS ¿ JPA JPA ROCHE DIAGNOSTICS 497A H7

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR SIMVASTATIN DOSE UNK| TOPROL XL DOSE UNK| LISINOPRIL DOSE UNK| AMARYL DOSE UNK| VISOPRIL/HCTZ DOSE UNK| COUMADIN - 5MG DAY| ASPIRIN DOSE UNK