BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1585919 · Received January 21, 2010

    Report

    Report Number
    1823260-2010-00429
    Event Type
    Injury
    Date Received
    January 21, 2010
    Date of Event
    December 25, 2009
    Report Date
    February 18, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    GJS
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN FOREIGN COUNTRY.

    Description of Event or Problem · 1

    CALLER STATES PT HAD BEEN INTERPRETING HIS INR VALUES AS %QUICK (UNK HOW LONG PT HAD ASSUMED HIS VALUES WERE IN %QUICK). CALLER STATES PT TESTED 1.1 INR ON THE COAGUCHECK XS SYSTEM AND ASSUMED THE RESULT WAS ACTUALLY 11 %QUICK. APPROXIMATELY 3-4 HRS LATER, THE PT WENT TO THE HOSP DUE TO A THROMBOSIS; HE TESTED 1.15 INR ON PROFESSIONAL DEVICE AND WAS IN SURGERY 30 MINUTES LATER. PT'S CURRENT CONDITION IS NOT KNOWN. REQUESTED RETURN OF SUSPECT DEVICE, AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    CALLER STATES PATIENT HAD BEEN INTERPRETING HIS INR VALUES AS %QUICK (UNKNOWN HOW LONG PATENT HAD ASSUMED HIS VALUES WERE IN %QUICK). CALLER STATES PATIENT TESTED 1.1 INR ON THE COAGUCHECK XS SYSTEM AND ASSUMED THE RESULT WAS ACTUALLY 11 %QUICK. APPROXIMATELY 3-4 HOURS LATER, THE PATIENT WENT TO THE HOSPITAL DUE TO A THROMBOSIS; HE TESTED 1.15 INR ON PROFESSIONAL DEVICE AND WAS IN SURGERY 30 MINUTES LATER. PATIENT'S CURRENT CONDITION IS NOT KNOWN. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS - NA GJS ROCHE DIAGNOSTICS CORP. 20174235

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R