BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 776423 · Received August 28, 2006

    Report

    Report Number
    1823260-2006-04728
    Event Type
    Malfunction
    Date Received
    August 28, 2006
    Report Date
    August 2, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER CALLED AND ALLEGED DISCREPANT RESULTS WHEN COMPARED TO THE LAB. THE REPORTED DEVICE RESULTS WERE 5.0 INR ON 7/31/2006 FOR PT 1 AND 5.1 INR ON 7/25/2006 FOR PT 2. THE CORRESPONDING LAB RESULTS REPORTED WERE 3.8 AND 2.4 INR. COUMADIN WAS HELD ON 7/31/06 FOR PT 1. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS NA 284A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR COREG| MAGNESIUM| SPIROLACTONE| LASIX| LOTENSIN| ASPIRIN| LOVESTATIN| METER CATALOG 2032074| COUMADIN
    2 71 YR