BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3012345 · Received March 20, 2013

    Report

    Report Number
    1823260-2013-01671
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    January 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 5.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS >8.0 INR. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM HOWEVER, THE CALLER DID NOT HAVE PATIENT INFORMATION TO REQUEST PRODUCT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116044 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1