BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® S SYSTEM

    MDR report key: 1904302 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06900
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 8, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE SHUNT SENSOR LEAKED. THE PRODUCT WAS CHANGED OUT. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING PRIME. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 5.0 INR ON THE COAGUCHEK S SYSTEM AND 3.0 INR ON A COMPARISON LAB. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. CALLER STATES THAT HE NO LONGER HAS THE STRIPS, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® S SYSTEM PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS 941A

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR COUMADIN (DAILY)| POTASSIUM CHLORIDE| LASIX (DAILY)| COLCHICINE (DAILY)| PROPRANOLOL HYDROCHLORIDE (DAILY)