BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU480 WITH ISE CHEMISTRY SYSTEM

    MDR report key: 1908432 · Received November 27, 2010

    Report

    Report Number
    2050012-2010-01453
    Event Type
    Malfunction
    Date Received
    November 27, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JLB
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OF CK CONTROLS WERE OUT OF RANGE. THE ROOT CAUSES ARE FAILURE OF THE USER: A. TO PREPARE THE CK REAGENT PER INSTRUCTION FOR USE. B. TO ADEQUATELY REVIEW CONTROL RESULTS THE PATIENTS RESULTS WERE REPORTED OUT OF THE LAB.

    Additional Manufacturer Narrative · 1

    ALL OF CK CONTROLS WERE OUT OF RANGE. THE ROOT CAUSES ARE FAILURE OF THE USER: TO PREPARE THE CK REAGENT PER INSTRUCTION FOR USE. TO ADEQUATELY REVIEW CONTROL RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO SEVERAL PATIENTS (200-300) LOW RESULTS FOR CREATININE KINASE (CK) GENERATED BY THE AU481-02E CHEMISTRY ANALYZER (AU480 WITH ISE). THE PATIENTS RESULTS WERE REPORTED OUT OF THE LAB. AVAILABLE PATIENT SAMPLES (5) WERE RETESTED AND HIGHER RESULTS WERE OBTAINED. UNKNOWN IF PATIENT TREATMENT WAS ADMINISTERED OR WITHHELD. DOCTORS WERE CONTACTED AND PROVIDED WITH A LIST OF PATIENT POTENTIALLY AFFECTED AND ASKED TO REPORT ANY MEDICAL ACTION TAKEN, IF ANY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO SEVERAL PATIENTS (200-300) LOW RESULTS FOR CREATININE KINASE (CK) GENERATED BY THE (B)(4) CHEMISTRY ANALYZER (AU480 WITH ISE). THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LAB. AVAILABLE PATIENT SAMPLES (5) WERE RETESTED AND HIGHER RESULTS WERE OBTAINED. UNKNOWN IF PATIENT TREATMENT WAS ADMINISTERED OR WITHHELD. DOCTORS WERE CONTACTED AND PROVIDED WITH A LIST OF PATIENT POTENTIALLY AFFECTED AND ASKED TO REPORT ANY MEDICAL ACTION TAKEN, IF ANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU480 WITH ISE CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JLB BECKMAN COULTER MISHIMA K.K. AU480-ISE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1