BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 4220962 · Received November 3, 2014

    Report

    Report Number
    1823260-2014-08469
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    August 19, 2014
    Report Date
    November 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    REPORTER STATED PATIENT TESTED 6.7 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 4.3 INR. IT WAS REPORTED THAT THE PATIENT WAS DOUBLE DOSED ON THE WARFARIN DOSE PRIOR TO THESE RESULTS AS THE GROUP HOME DID NOT KNOW WHAT THE PATIENT WAS SUPPOSED TO BE TAKING. PATIENT HAS SINCE RETURNED TO TAKING HER NORMAL WARFARIN DOSE OF 5 MG. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, THE SUSPECT STRIPS ARE NO LONGER AVAILABLE TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702674 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR LISINOPRIL| TRAZODONE| WARFARIN| BACTRIM| BUSPAR| MACRODANTIN| BACLOFEN| DEPAKOTE| LEXAPRO| GABAPENTIN| SYNTHROID| OMEPRAZOLE| SIMVASTATIN