BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGOXIN

    MDR report key: 2081148 · Received May 9, 2011

    Report

    Report Number
    1823260-2011-02461
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KXT
    PMA / PMN Number
    K973112
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR DIGOXIN AND OTHER ASSAYS FROM THE COBAS E601 ANALYZER SERIAL NUMBER (B)(4). ONLY DATA FOR ONE PATIENT FOR THE DIGOXIN ASSAY WAS PROVIDED. THE INITIAL RESULT WAS 2.54 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 2.58 NG/ML WITH A DATA FLAG. THE SAMPLE WAS THEN TESTED ON THE OTHER MEASURING CELL OF THE ANALYZER AND THE RESULT WAS 1.64 NG/ML. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY AND A CORRECTED REPORT WAS LATER SENT. THE PATIENT WAS NOT ADVERSELY AFFECTED. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A LOOSE TUBING CONNECTION ON THE MEASURING CELL. HE TIGHTENED THE CONNECTION AND PRIMED THE SYSTEM. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION, QUALITY CONTROL AND PRECISION TESTING WITH ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGOXIN ENZYME IMMUNOASSAY, DIGOXIN KXT ROCHE DIAGNOSTICS NA 15926001

    Patients

    Seq Age Sex Outcome Treatment
    1