BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS ISE MODULE

    MDR report key: 8621150 · Received May 17, 2019

    Report

    Report Number
    1823260-2019-01875
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 22, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOUND THE ISSUE WAS CONSISTENT WITH PRE-ANALYTICAL FACTORS.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE ISE INDIRECT NA AND K FOR GEN.2 RESULTS FOR 1 PATIENT TESTED ON TWO DIFFERENT COBAS 8000 COBAS ISE MODULE (DOUBLE) ANALYZERS. THE CUSTOMER DID NOT KNOW WHICH ANALYZER HAD CORRECT RESULTS. NO RESULTS IN QUESTION WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER ISE MODULE (B)(4). REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON ISE MODULE SERIAL NUMBER (B)(4). THE SODIUM RESULTS FROM SERIAL NUMBER (B)(4) WERE 141 MMOL/L AND 147 MMOL/L. THE POTASSIUM RESULTS FROM SERIAL NUMBER (B)(4) WERE 5.4 MMOL/L AND 5.6 MMOL/L. THE SODIUM RESULT FROM SERIAL NUMBER (B)(4) WAS 154 MMOL/L. THE POTASSIUM RESULT FROM SERIAL NUMBER (B)(4) WAS 5.9 MMOL/L. THERE WAS NO ADVERSE EVENT FOR SERIAL NUMBER (B)(4), THE INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414922 COBAS 8000 COBAS ISE MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS COBAS 8000 ISE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR