BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU400 WITH ISE CHEMISTRY SYSTEM

    MDR report key: 1891210 · Received November 4, 2010

    Report

    Report Number
    2050012-2010-01161
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JGS
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) ALIGNED THE RACK FEEDER AND BARCODE READER MIRROR. FSE RAN SEVERAL RACKS AND SAMPLES WITHOUT ERRORS. A CLEAR ROOT CAUSE IS UNDETERMINED FOR THIS EVENT. CHANGE: FROM (B)(4) 2010 TO (B)(4) 2010.

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) ALIGNED THE RACK FEEDER AND BARCODE READER MIRROR. A CLEAR ROOT CAUSE IS UNDETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE LOW RESULT FOR SODIUM (NA), GENERATED BY THE AU400E-ISE CLINICAL CHEMISTRY ANALYZER FOR ONE PATIENT. THE PATIENT RESULT WAS NOT REPORTED OUT OF THE LAB. THE INITIAL SAMPLE WAS REPEATED AND HIGHER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT AFFECTED BY THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE LOW RESULT FOR SODIUM (NA), GENERATED BY THE (B)(4) CLINICAL CHEMISTRY ANALYZER FOR ONE PATIENT. THE PATIENT RESULT WAS NOT REPORTED OUT OF THE LAB. THE INITIAL SAMPLE WAS REPEATED AND HIGHER RESULT WAS OBTAINED. PATIENT RESULTS ARE PROVIDED. PATIENT TREATMENT WAS NOT AFFECTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU400 WITH ISE CHEMISTRY SYSTEM AU400 WITH ISE CHEMISTRY ANALYSER, JGS BECKMAN COULTER MISHIMA K.K. AU400-ISE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1