BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400+

    MDR report key: 1780974 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06555
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    June 30, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    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

    AN ACCOUNT REPORTED THEY EXPERIENCED TWO DISCREPANT RESULT EVENTS. THE FIRST EVENT OCCURRED ON (B)(6)07 WHEN A PATIENT SODIUM RESULT WAS INITIALLY 130 MMOL/L AND REPEATED AS 137 MMOL/L AND 139 MMOL/L. THE SECOND EVENT OCCURRED ON (B)(6)07 WHEN A PATIENT GLUCOSE RESULT WAS INITIALLY 273 MG/DL AND REPEATED AS 132 MG/DL. A SECOND REPEAT ON ANOTHER INSTRUMENT GAVE A RESULT OF 135 MG/DL. THE INCORRECT SODIUM RESULT WAS NOT REPORTED AND THE INCORRECT GLUCOSE RESULT WAS REPORTED, BUT WAS NOT USED TO GUIDE TREATMENT. THE FIELD SERVICE REP FOUND THE PROBE WAS DAMAGED AND REPAIRED THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA