BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1901226 · Received November 17, 2010

    Report

    Report Number
    1823260-2010-06789
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 23, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER TESTED 2.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.76 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS AND PROVIDED DATA FOR TWO PATIENT SAMPLES. REPEAT TESTING WAS PERFORMED (B)(6) 2010 ON COBAS C501 ANALYZER SERIAL NUMBER (B)(4). ALL RESULTS ARE IN MMOL/L. PATIENT SAMPLE 1 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 140. PATIENT SAMPLE 2 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 140. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT. THE LOT NUMBER OF THE SODIUM ELECTRODE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. HE VERIFIED THE ANALYZER OPERATION WITH SUCCESSFUL ISE CHECKS, PRECISION TESTING WITH RESULTS WITHIN THE ACCEPTABLE RANGE AND QUALITY CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS 20180432

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR BISOPROLOL| "AORTIC VALVE"| COUMADIN| RAMIPRIL| AZATHIOPRINE