BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® S SYSTEM

    MDR report key: 2192680 · Received August 5, 2011

    Report

    Report Number
    1823260-2011-04214
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 21, 2011
    Report Date
    September 21, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. PATIENT 2 - (B)(6) OLD MALE SECTION D11: PATIENT 2 - WARFARIN, AMIODARONE THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE COAGUCHEK S SYSTEM (LOT NUMBER 959A, EXPIRATION DATE 03/31/2012). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE COAGUCHEK XS SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/S RESULTS WERE OBTAINED: 1.9 INR/2.4 INR, 3.2 INR/4.3 INR, 4.6 INR/6.5 INR PATIENT 2'S WEEKLY WARFARIN DOSE WAS DECREASED BASED ON METER READING. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK ® S SYSTEM PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS NA 959A

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR WARFARIN