BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK PT TEST STRIPS

    MDR report key: 594934 · Received April 20, 2005

    Report

    Report Number
    1823260-2005-00722
    Event Type
    Malfunction
    Date Received
    April 20, 2005
    Date of Event
    March 30, 2005
    Report Date
    March 30, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    TWO PT'S WERE TESTED ON THE SUSPECT DEVICE WITH INR RESULTS >8. PT #1 LAB INR WAS 5.6 AND PT #2 LAB INR WAS 6.2. CONTROLS WERE IN RANGE. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK PT TEST STRIPS PROTHOMBIN TIME JPA ROCHE DIAGNOSTICS NA 988 C4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN