BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2935924 · Received January 30, 2013

    Report

    Report Number
    1823260-2013-00546
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER TESTED 8.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 5.6 INR. CALLER'S COUMADIN WAS HELD FOR 5 DAYS BASED ON THE LAB VALUE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41528 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21625121

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR COUMADIN| ARTIFICIAL "HEART" VALVE| UNKNOWN CHEMOTHERAPY| ASPIRIN