BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400+

    MDR report key: 1752603 · Received August 15, 2007

    Report

    Report Number
    1823260-2007-07114
    Event Type
    Malfunction
    Date Received
    August 15, 2007
    Date of Event
    July 26, 2007
    Report Date
    August 15, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTED LOW PATIENT SODIUM RESULTS AND GAVE THE FOLLOWING EXAMPLES (INITIAL RESULT/REPEAT RESULT MMOL/L): 133/139, 130/138, 129/138, 133/140, 125/138, 130/141, 132/142, 131/141, 133/140, 133/141, 131/140, 131/139, 129/138, 126/134. THE ACCOUNT DID NOT INDICATE THAT ANY ADVERSE EVENTS WERE ASSOCIATED WITH THE INCORRECT RESULTS. THE FIELD SERVICE REP FOUND THE PROBE WAS CLOGGED AND THE ISE REAGENT WAS CONTAMINATED AND REPAIRED THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400+ CLINICAL CHEMISTRY ANALYZER - JJE JGS ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CUSTOMER DECLINED TO GATH