BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1813305 · Received August 24, 2010

    Report

    Report Number
    1823260-2010-05052
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 3.1 INR AND 2.3 INR ON THE COAGUCHEK XS SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    RECEIVED USER-FACILITIES REPORT VIA FDA EVENT DESC: DURING A SURGICAL PROCEDURE OF PATIENT'S UPPER ARM, WHEN ATTENTION WAS TURNED TO FIXATION OF THE TRICEPS, A DRILL BIT WAS USED TO CREATE HOLES IN THE OLECRANON FOR RE-ATTACHMENT OF THE TRICEPS. DURING THIS TIME, IT WAS NOTED THAT 1 OF THE DRILL BITS BROKE. THIS WAS CONFIRMED WITH THE C-ARM (X-RAY IMAGE INTENSIFIER). THE DRILL WAS NOTED TO HAVE EMERGED ON THE RADIAL SIDE OF THE OLECRANON AND IT WAS IDENTIFIED WITH THE C-ARM AND REMOVED WITH A HEMOSTAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20180721

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR LOVASTATIN| CVS HEARTBURN RELIEF CIMETIDINE| FUROSEMIDE| KLOR-CON| LANTUS INSULIN| RAMIPRIL| HUMALOG INSULIN| SOTALOL| BABY ASPIRIN| WARFARIN| XALATAN| DEFIBRILLATOR| "STECTRAVITE SENIOR"| CALCIUM