BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 1235407 · Received November 17, 2008

    Report

    Report Number
    1823260-2008-08491
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 17, 2008
    Manufacturer
    HITACHI HIGH TECH CORP.
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED A HIGH SODIUM VALUE FOR ONE PT SAMPLE. NO EXACT PT DATA WAS GIVEN. THE SAMPLE INITIALLY REPORTED AROUND 200 MMOL/L AND REPEATED WITHIN THE NORMAL RANGE OF 133 MMOL/L TO 145 MMOL/L. THE HIGH PT SAMPLE WAS NOT REPORTED AND ONLY THE VALUE THAT FELL BETWEEN 133 MMOL/L AND 145 MMOL/L WAS REPORTED. USER WAS UNABLE TO PROVIDE INFO TO DETERMINE IF PT WAS ADVERSELY AFFECTED. THE USER REFUSED A SERVICE VISIT FROM THE FIELD SERVICE REP. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 CORE CLINICAL CHEMISTRY ANALYZER - CEM JJE HITACHI HIGH TECH CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK