BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 2457413 · Received February 16, 2012

    Report

    Report Number
    1823260-2012-00959
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 16, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM, CHLORIDE AND CALCIUM RESULTS FOR ONE PATIENT SAMPLE. OF THE DATA PROVIDED, ONLY THE SODIUM RESULTS WERE DISCREPANT. THE INITIAL RESULT WAS 152 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 143, 166, 145, AND 145 MMOL/L. THE USER STATED THEY WERE NOT SURE WHICH RESULT WAS CORRECT. THE RESULTS OF 152 AND 143 MMOL/L WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE LOT NUMBER AND EXPIRATION DATE OF THE SODIUM ELECTRODE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND THE MIX TOWER TO BE PITTED AND REPLACED THE TOWER. TO VERIFY THE ANALYZER OPERATION HE RAN CALIBRATION, QUALITY CONTROL AND PRECISION TESTING WITH ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1