BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 4131382 · Received October 1, 2014

    Report

    Report Number
    1823260-2014-07478
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 12, 2014
    Report Date
    October 2, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT NOT PROVIDED. POSSIBLE ROOT CAUSES FOR THIS TYPE OF EVENT ARE: AIR IN THE ELECTRODE OR REFERENCE LINE OR LEAKS OR SHORT CIRCUITS TO THE GROUND POTENTIAL. HOWEVER, THESE CAUSES COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE SODIUM AND POTASSIUM RESULTS FOR ONE PATIENT ON THEIR INTEGRA 400 PLUS ANALYZER. THE CUSTOMER PROVIDED DATA FOR ONE DISCREPANT SODIUM RESULT. THE PATIENT'S INITIAL SODIUM RESULT WAS 124 MEQ/L AND IT WAS RELEASED TO THE PHYSICIAN. THE INITIAL RESULT DID NOT MATCH THE CLINICAL HISTORY OF THE PATIENT AND THE PHYSICIAN ASKED FOR A CONFIRMATION OF THE RESULT. THE SAMPLE WAS REPEATED THREE TIMES AND THE RESULTS WERE 137 MEQ/L, 137 MEQ/L, AND 137 MEQ/L. AFTER CONFIRMATION, THE FOURTH RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SODIUM ELECTRODE LOT NUMBER WAS 33141 AND THE INSTALL BY DATE WAS (B)(6) 20140. ALL THE ELECTRODES WERE REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611277 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 013 YR MTX (METHOTREXATE)| CICLOFOSFAMIDA