BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2060502 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01189
    Event Type
    Malfunction
    Date Received
    April 18, 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
    2050012-09/01/2010-028C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI HOTLINE ASSISTED THE CUSTOMER WITH PERFORMING THE CUVETTE OVERFLOW RECOVERY PROCEDURE. THE LABORATORY DID NOT RUN CREATININE ON THE ORIGINAL ANALYZER AGAIN BECAUSE THE ACCOUNT SWITCHED TO A NEW ANALYZER. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. ROOT CAUSE IS DUE TO CUVETTE OVERFLOW AFFECTING THE CUVETTES. BCI INTERNAL CORRECTION/REMOVAL REPORTING NUMBER: 2050012-09/01/2010-028C.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY LOW CREATININE (CRE) RESULT THAT WAS REPORTED OUT OF THE LABORATORY, GENERATED BY THE AU400 CLINICAL CHEMISTRY ANALYZER. THE ORIGINAL CRE RESULT WAS 0.69 MG/DL. THE SAMPLE WAS RETESTED ON AN ALTERNATE INSTRUMENT YIELDING A RESULT OF 0.90 MG/DL. NO AFFECT TO PATIENT TREATMENT 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1