BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE UNIT 150

    MDR report key: 1780579 · Received September 26, 2007

    Report

    Report Number
    1823260-2007-08406
    Event Type
    Malfunction
    Date Received
    September 26, 2007
    Date of Event
    September 3, 2007
    Report Date
    September 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER OBTAINED DISCREPANT SODIUM AND POTASSIUM RESULTS FOR A PATIENT SAMPLE. INITIAL RESULTS: NA 87, K 2.1 MMOL/L. WHEN REPEATED, THE RESULTS WERE NA 136 AND K 3.6 MMOL/L. THE ACCOUNT DID NOT REPORT ANY ADVERSE EVENTS ASSOCIATED WITH THE INCORRECT RESULT. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 CORE UNIT 150 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK