BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 CORE UNIT

    MDR report key: 8514376 · Received April 15, 2019

    Report

    Report Number
    1823260-2019-01452
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 15, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT GEN.2 RESULTS FOR ONE PATIENT FROM A COBAS 8000 ANALYZER COMPARED TO A VITROS ANALYZER AND A BLOODGAS ANALYZER OVER SEVERAL DAYS. THE CUSTOMER SUSPECTED INTERFERENCE DUE TO THE MEDICATION FLAMMACERIUM TAKEN BY THE PATIENT. IT WAS UNCLEAR IF THE SAME SAMPLE WAS USED FOR TESTING ON THE DIFFERENT ANALYZERS. THE SODIUM RESULTS FROM THE COBAS 8000 ANALYZER WERE 151-153 MMOL/L. THE SODIUM RESULTS FROM THE OTHER ANALYZER WERE 144-148 MMOL/L. THE POTASSIUM RESULTS FROM THE COBAS 8000 ANALYZER WERE 3.4-5.6 MMOL/L. THE POTASSIUM RESULTS FROM THE OTHER ANALYZER WERE 3.4-5.1 MMOL/L. THE CHLORIDE RESULTS FROM THE COBAS 8000 ANALYZER WERE 102-125 MMOL/L. THE CHLORIDE RESULTS FROM THE OTHER ANALYZER WERE 117-123 MMOL/L. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT WERE NOT PROVIDED. AS ALL ISE PARAMETERS APPEARED TO BE AFFECTED, DIRECT INTERFERENCE CAUSED BY FLAMMACERIUM COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308267 COBAS 8000 CORE UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS COBAS 8000 CORE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 FLAMMACERIUM