BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 810837 · Received June 8, 2006

    Report

    Report Number
    1823260-2006-02660
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    May 15, 2006
    Report Date
    May 16, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS ALSO TESTED ON DEVICE 2032074 WITH A RESULT OF >8 INR. THE REPORTER DID NOT WANT A REPLACEMENT PRODUCT BECAUSE SHE FELT THIS WAS NOT METER RELATED BECAUSE THE RESULT WAS THE SAME ON BOTH METERS.

    Description of Event or Problem · 1

    THE REPORTED CALLED AND ALLEGED A DISCREPANT RESULT WHEN COMPARED TO A LAB. THE REPORTED DEVICE RESULT WAS >8 INR. THE CORRESPONDING LAB RESULT REPORTED WAS 3.34 INR. THE PT WAS GIVEN A VITAMIN K SHOT AND TOLD TO COME BACK THE NEXT DAY. THE NEXT DAY HER INR WAS 2.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS NA 218A

    Patients

    Seq Age Sex Outcome Treatment
    1 * METER 2032074| COUMADIN.