BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2163106 · Received July 15, 2011

    Report

    Report Number
    1823260-2011-03767
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER TESTED 1.7 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 7.9 INR. CALLER'S WARFARIN DOSE WAS HELD FOR 3 DAYS BASED ON LAB VALUE. 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 20131222

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR WARFARIN| CENTRUM SILVER DAILY| VITAMIN B12 DAILY| VITAMIN D ONCE DAILY| GABAPENTIN| VITAMIN E ONCE DAILY| FEXOFENADINE| CARVEDILOL| ESTER-C ONCE DAILY| FISH OIL ONCE DAILY| NUCYNTA