BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU2701-02 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1823128 · Received September 1, 2010

    Report

    Report Number
    2050012-2010-00690
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 2, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K002982
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. INCORRECT VERSION OF PARAMETER SETTINGS WERE USED. THE PARAMETER SETTINGS WERE CORRECTED AND PRECISION, LINEARITY, AND METHOD COMPARISON RUNS WERE PERFORMED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY HIGH PHENYTOIN RESULTS GENERATED ON AU2701-02 CHEMISTRY ANALYZER. THE CUSTOMER REPORTED OUT THE RESULTS FLAGGED ABOVE DYNAMIC RANGE OF PHENYTOIN, AND A NURSE SPECIALIST QUESTIONED THE RESULTS. WHILE TROUBLESHOOTING WITH BCI HOTLINE, IT WAS DISCOVERED THAT THE PARAMETER SETTINGS WERE INCORRECT. THE CUSTOMER REPEATED TESTING WITH CORRECT PARAMETER SETTINGS. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU2701-02 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1