BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 4092876 · Received September 16, 2014

    Report

    Report Number
    1823260-2014-07040
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    December 13, 2013
    Report Date
    September 16, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    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

    CALLER TESTED 7.2 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 10.3 INR. CALLER WAS ADMITTED TO THE HOSPITAL BASED ON THE LAB RESULT AND TREATED WITH 2 IV'S CONTAINING VITAMIN K. NO ADVERSE EVENT DUE TO THE DEVICE RESULT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, THE CUSTOMER NO LONGER HAS THE STRIPS THAT WERE IN USE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571400 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR DIGOXIN| SONATA| WARFARIN| ASPIRIN| ISOSORBIDE| NO OTHER MEDICAL DEVICES| DIPHENHYDRAMINE| RANEXA| DIAZEPAM| CRESTOR| CARVEDILOL| STOOL SOFTENER| PREVACID