BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 3230052 · Received July 16, 2013

    Report

    Report Number
    1823260-2013-04279
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 3.0 INR ON THE COAGUCHEK XS PLUS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.2 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, TEST STRIPS WERE NOT RETURNED; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328690 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21624911

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR SALBUTAMOL INHALER| OMEPRAZOLE| FUROSEMIDE| "MICRORANDUR"| CARBOCISTEINE| LACTULOSE| WARFARIN| NASAL O2| ATORVASTATIN| CARVEDILOL| FINASTERIDE