BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 4092236 · Received September 16, 2014

    Report

    Report Number
    1823260-2014-07030
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. CUSTOMER ADVISED THAT SHE USED THE REMAINING STRIPS. THERE ARE NO REMAINING STRIPS TO RETURN. DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER TESTED 7.1 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 4.3 INR. CUSTOMER'S COUMADIN DOSE WAS LOWERED. CUSTOMER HAD A BLOODY NOSE AT THE TIME OF THE 7.1 INR RESULT. AFTER THE LAB, AN URGENT CARE EMPLOYEE PACKED HER NOSE. NO FURTHER TREATMENT WAS REQUIRED. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571018 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21924421

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR PLAVIX| COUMADIN