BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2875094 · Received December 17, 2012

    Report

    Report Number
    1823260-2012-06339
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 19, 2012
    Report Date
    January 25, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 5.8 INR, 3.7 INR, AND 3.7 INR ON THE COAGUCHEK XS SYSTEM. CALLER STATES PATIENT'S BLOOD APPEARED "THIN AND RUNNY" WITH THE 5.8 INR RESULT. NO ACTIONS WERE TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND 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 21432622

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR ASPIRIN ONCE DAILY| LIPITOR| VITAMIN D3| DILTIAZEM| LASIX| PROGESTERONE| COUMADIN| TOPROL XL| SYNTHROID ONCE DAILY| DIOVAN