BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2062863 · Received April 19, 2011

    Report

    Report Number
    2050012-2011-01172
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K981743
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CUSTOMER SERVICE TALKED THE CUSTOMER THROUGH PERFORMING CUVETTE OVERFLOW RECOVERY PROCEDURE. CUSTOMER DID NOT RUN CREATININE ON THE AU400 ANALYZER AGAIN AND FIELD SERVICE ENGINEER WAS NOT DISPATCHED FOR THIS EVENT. ROOT CAUSE FOR ERRONEOUS RESULTS IS ASSOCIATED WITH CUVETTE OVERFLOW.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT OBTAINING AN ERRONEOUS CREATININE RESULT GENERATED BY THE AU400 CLINICAL CHEMISTRY ANALYZER FOR ONE (1) PATIENT. THE ERRONEOUS RESULT YIELDED 1.06 MG/DL AND 1.5 MG/DL ON AN ALTERNATE INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB. NO EFFECT TO PATIENT WAS REPORTED WITH REGARD TO THE ERRONEOUS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU400 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1