BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1941311 · Received December 29, 2010

    Report

    Report Number
    2050012-2010-01779
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K981743
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES BEFORE AND AFTER THE EVENT. REAGENT BLANK READING INDICATED POSSIBLE EXCESS OF HCO3 IN THE DI WATER WHICH CAN CAUSE HIGHER RECOVERY OF RESULTS. BCI CALL CENTER DIAGNOSED A WATER PROBLEM BASED ON REAGENT BLANK READINGS, AND THE CUSTOMER WILL HAVE WATER COMPANY SERVICE THE INSTRUMENT. THE WATER PROBLEM HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED CARBON DIOXIDE (CO2) RESULTS GENERATED BY AU400 CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND WERE QUESTIONED BY A PHYSICIAN. SUBSEQUENT TESTING AFTER RECALIBRATION OF THE ANALYZER PRODUCED RESULTS IN THE NORMAL REFERENCE RANGE. THERE WAS NO EFFECT TO PATIENTS.

    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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1