BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1910043 · Received November 30, 2010

    Report

    Report Number
    1823260-2010-07050
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD HAD IMPEDANCE OF 109 OHMS BIPOLAR AND CAPTURE THRESHOLD WERE 4 VOLTS WITH NO CAPTURE IN UNIPOLAR POLARITY. INSULATION BREACH WAS SUSPECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD EXPIRED. FOLLOW UP REPORTED DEVICE CHECK (B)(6) 2008 SHOWED ATRIAL LEAD WARNING WITH LOW IMPEDANCE IN BIPOLAR. REPROGRAMMING HAD BEEN TRIED, BUT PATIENT WOULD NOT TOLERATE UNIPOLAR. SCHEDULED TO FOLLOW UP IN ONE MONTH. IN (B)(6) 2009, CARDIOLOGIST QUESTIONING PACEMAKER MALFUNCTION AND TOLD "TOP LEAD NOT WORKING." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 4.1 INR ON COAGUCHEK XS SYSTEM 1 AND 2.0 INR ON COAGUCHEK XS SYSTEM 2. CALLER STATES THAT THE DOCTOR USED THE SECOND RESULT FOR TREATMENT BUT DID NOT SPECIFY WHAT THAT TREATED WAS. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS 20182531

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR COUMADIN (DAILY)