BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2760107 · Received September 26, 2012

    Report

    Report Number
    1823260-2012-04818
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Description of Event or Problem · 1

    CALLER TESTED 1.4 INR ON THE COAGUCHEK XS SYSTEM, WHILE A COMPARISON LAB RETURNED AS 1.9 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM HOWEVER, CALLER NO LONGER HAS ANY TEST STRIPS TO RETURN, THE CALLER ONLY HAS THE EMPTY STRIP VIAL. REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21416722

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR COUMADIN| ARTIFICIAL AORTIC VALVE| LOVENOX