BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® SYSTEM

    MDR report key: 1912823 · Received December 2, 2010

    Report

    Report Number
    1823260-2010-07120
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 23, 2010
    Report Date
    February 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN COAGUCHEK S SYSTEM 2 (LOT NUMBER 885AC7, EXPIRATION DATE 12/31/2010). (B)(6).

    Description of Event or Problem · 1

    CALLER TESTED 4.1 INR ON COAGUCHEK S SYSTEM 1 AND 4.7 INR ON COAGUCHEK S SYSTEM 2 WHILE A COMPARISON LAB RETURNED AS 2.9 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 885AC7

    Patients

    Seq Age Sex Outcome Treatment
    1 022 YR "PREDNISLONE" DAILY| SOTALOL 3 TIMES DAILY| MECHANICAL HEART VALVE| "OMPREGOL" ONCE DAILY| EPLERENONE 3 TIMES DAILY| WARFARIN DAILY| "FRUZIMIDE" ONCE DAILY