BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK PT TEST STRIPS

    MDR report key: 689154 · Received March 10, 2006

    Report

    Report Number
    1823260-2006-01146
    Event Type
    Malfunction
    Date Received
    March 10, 2006
    Date of Event
    February 27, 2006
    Report Date
    February 28, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER CALLED AND ALLEGED DISCREPANT RESULTS WHEN COMPARED TO A LAB. THE REPORTED DEVICE RESULT WAS 8.0 AND 6.0 INR. THE CORRESPONDING LAB RESULT REPORTED WAS 3.4 AND 3.2 INTR, THE FIRST COMPARISON WAS PERFORMED ON 2/13/2006

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK PT TEST STRIPS PROTHROMBIN TIME JPA ROCHE DIAGNOSTICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *