BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2761012 · Received September 26, 2012

    Report

    Report Number
    1823260-2012-04845
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 23, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CALLER DID NOT KNOW WHICH STRIP LOT PRODUCED THE DISCREPANT RESULTS. LOTS 21202611 (EXPIRATION DATE 08/31/2013) AND 21132611 (EXPIRATION DATE 06/30/2013) WERE IN USE BY THE CALLER AT THE TIME OF THE EVENT. IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE RETENTION STRIPS FOR BOTH LOTS WERE TESTED ON RETENTION METERS. NO ERROR MESSAGES OCCURRED AND THE RETENTION STRIPS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 4.1 INR AND 3.1 INR ON THE COAGUCHEK XS PLUS SYSTEM. NO TREATMENT INFORMATION PROVIDED. 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 ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN