BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2122211 · Received June 13, 2011

    Report

    Report Number
    1823260-2011-03217
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    April 19, 2011
    Report Date
    August 8, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE COAGUCHEK XS SYSTEM (LOT NUMBER 20306211, EXPIRATION DATE 06/30/2012). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN COAGUCHEK S SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/S RESULTS WERE OBTAINED: 3.0 INR/2.2 INR NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CALLER HAS DISCARDED THE TEST STRIPS; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20306211

    Patients

    Seq Age Sex Outcome Treatment
    1