BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU640 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1814842 · Received August 25, 2010

    Report

    Report Number
    2050012-2010-00611
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. BASED ON THE INVESTIGATION, THE CUVETTE OVER FLOW HAD CONTRIBUTED TO THIS EVENT. THE FSE VERIFIED THE INSTRUMENT'S PERFORMANCE AND QC RUN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING REPORTS OF FALSELY LOW CRP (C-REACTIVE PROTEIN) AND HSCRP RESULTS GENERATED BY THE AU640 CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LAB. THE ORIGINAL SPECIMENS WERE RE-TESTED AND CORRECTED REPORTS WERE ISSUED. PATIENT TREATMENT WAS NOT IMPACTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU640 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU640 NA

    Patients

    Seq Age Sex Outcome Treatment
    1