BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5800 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3831201 · Received May 23, 2014

    Report

    Report Number
    9612296-2014-00079
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K112412
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND THAT THE CUSTOMER HAD ALREADY CORRECTED THE ISSUE. THE FSE CONFIRMED THAT THERE WAS PREVIOUSLY AN OVERFLOW ON THE INSTRUMENT'S DAUGHTER TANK. THE CUSTOMER REPORTED THAT THERE WAS A BUILD-UP OF CRYSTALLIZED DETERGENT ON THE FLOAT SLIDE THAT PREVENTED THE FLOAT FROM MOVING FREELY. THE FLOAT WAS NOT ABLE TO DETECT DETERGENT VOLUME IN THE DAUGHTER TANK, THUS IT DID NOT SIGNAL TO THE INSTRUMENT TO TURN THE PUMP OFF, RESULTING IN AN OVERFLOW. THE FSE CONFIRMED THAT THE INSTRUMENT WAS OPERATING PER MANUFACTURER'S SPECIFICATIONS. THERE WERE NO FURTHER REPORTS OF LEAKS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVERFLOW OF DETERGENT FROM THE DETERGENT TANK OF AN AU5800 CLINICAL CHEMISTRY ANALYZER. THE OPERATOR WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT. THERE WERE NO REPORTS OF DIRECT CONTACT WITH THE LEAK OR OF INJURY AS A RESULT OF THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED AS A RESULT OF THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308228 AU5800 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU5800-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1