BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3232508 · Received July 18, 2013

    Report

    Report Number
    1823260-2013-04311
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    April 12, 2013
    Report Date
    July 24, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 3.9 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.1 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333352 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21625121

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR COUMADIN| BIPAP MACHINE| TOPROL DAILY| NEXIUM TWICE A DAY| PACEMAKER| EFFEXOR| NORVASC DAILY| DIGOXIN| FISH OIL TWICE A DAY| BABY ASPIRIN DAILY