BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1780361 · Received September 12, 2007

    Report

    Report Number
    1823260-2007-07961
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    January 1, 2007
    Report Date
    September 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THAT THE PT TESTED 2.9 INR ON THE COAGUCHEK S METER. A LAB TAKEN AT AN UNK TIME/DAY RETURNED AS 1.2 INR. CALLER STATES THAT THE PT HAD A STROKE (B)(6) 2007. NO INFO WAS PROVIDED AS TO WHETHER COMPARISONS WERE PERFORMED ON THE SAME DAY OR IF RESULTS WERE OBTAINED ON THE DAY PT HAD A STROKE. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIP - JPA JPA ROCHE DIAGNOSTICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA