BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3252728 · Received July 29, 2013

    Report

    Report Number
    1823260-2013-04530
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 29, 2013
    Report Date
    September 5, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER STATES, PATIENT TESTED 5.5 INR ON THE COAGUCHEK XS SYSTEM; A NURSE WAS IMMEDIATELY CONTACTED, AND THE PATIENT TESTED 2.6 INR ON THE NURSE'S NON-ROCHE SYSTEM. AN AMBULANCE WAS CALLED BECAUSE THE PATIENT HAD A LARGE HEMATOMA ON THE BACK OF HIS LEG. HE WAS TAKEN TO THE EMERGENCY ROOM (ER) WHERE A COMPARISON LAB RETURNED AS 2.4 INR. THE PATIENT RECEIVED NO MEDICAL TREATMENT AND WAS JUST KEPT IN THE ER OVERNIGHT FOR OBSERVATION. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352641 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21912021

    Patients

    Seq Age Sex Outcome Treatment
    1 084 YR COUMADIN DAILY| ATENOLOL| VITAMIN D| VITAMIN B| PRILOSEC| CELEXA| NAMENDA