BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS ISE MODULE

    MDR report key: 12150289 · Received July 12, 2021

    Report

    Report Number
    1823260-2021-01990
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    June 18, 2021
    Report Date
    August 4, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946341
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONFIRMED NO OTHER PATIENT SAMPLES WERE AFFECTED. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PREANALYTICAL SAMPLE HANDLING ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CHANGED THE SAMPLE PROBE AND REPEATED THE PATIENT'S SAMPLE FIVE TIMES ON THE SAME COBAS 8000 COBAS ISE MODULE. THE CUSTOMER VERIFIED THE PATIENT'S RESULTS CAME BACK ALL ACCURATE AND STABLE, AND THE CALIBRATION AND QC RESULTS WERE FINE. THE FIELD SERVICE ENGINEER PERFORMED AN ISE CHECK. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT GEN.2 NA RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 COBAS ISE MODULE. A QUESTIONABLE NA RESULT FROM THE COBAS 8000 COBAS ISE MODULE WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE PATIENT'S SAMPLE ON AN UNKNOWN "GAZ ANALYZER" AND ON THE SAME COBAS 8000 COBAS ISE MODULE. THE CUSTOMER DETERMINED THE NA RESULT OF 136 MMOL/L FROM THE "GAZ ANALYZER" WAS DETERMINED CORRECT AND THE NA RESULT WAS "REVISED." THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052958 COBAS 8000 COBAS ISE MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS COBAS 8000 ISE NA 04015630946341

    Patients

    Seq Age Sex Outcome Treatment
    1