BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3200115 · Received July 1, 2013

    Report

    Report Number
    1823260-2013-03975
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    October 23, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 5.1 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS >10.0 INR. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297724 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21625211

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR LEVOTHYROXINE| FENOFIBRATE| LOVASTATIN| WARFARIN| VITAMIN B12| CALCIUM/VITAMIN D| ATENOLOL/CHLORTHALIDONE| VITAMIN D| FISH OIL