BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS ISE MODULE

    MDR report key: 7595577 · Received June 13, 2018

    Report

    Report Number
    1823260-2018-01882
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 29, 2018
    Report Date
    June 13, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ISE INDIRECT GEN.2 RESULTS FOR ONE PATIENT SAMPLE FROM A COBAS 8000 COBAS ISE MODULE. THE SODIUM RESULTS WERE 124, 143, 144 MMOL/L. THE CHLORIDE RESULTS WERE 130, 105, 107 MMOL/L. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WAS REQUESTED, BUT IT WAS UNKNOWN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT WERE NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438232 COBAS 8000 COBAS ISE MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS COBAS 8000 ISE NA

    Patients

    Seq Age Sex Outcome Treatment
    1