BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2853457 · Received November 30, 2012

    Report

    Report Number
    1823260-2012-06062
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 2, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE INITIAL REPORTER HAS ALREADY OR INTENDS TO REPORT THE EVENT TO FDA. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT REPORTED OBTAINING A RESULT OF 4.6 INR ON THE COAGUCHEK XS SYSTEM. A LABORATORY TEST, PERFORMED WITHIN 10 MINUTES, REPORTED A RESULT OF 2.5 INR. PATIENT WAS ADVISED, BY PHYSICIAN, TO WITHHOLD HER COUMADIN DOSE AND RESUME NORMAL DOSE OF 2.5 MG THE FOLLOWING DAY. NO ADVERSE EVENT WAS REPORTED. AT THE TIME OF THE REPORT, PATIENT NO LONGER HAD THE TEST STRIPS WHICH PRODUCED THE RESULT. THE SUSPECT PRODUCT WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    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
    1 062 YR UNSPECIFIED BLOOD PRESSURE MEDICATION| OXYGEN MACHINE| COUMADIN| UNSPECIFIED PAIN MEDICAION| UNSPECIFIED ANXIETY MEDICATION