BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2357183 · Received December 4, 2011

    Report

    Report Number
    2050012-2011-08234
    Event Type
    Malfunction
    Date Received
    December 4, 2011
    Date of Event
    November 3, 2011
    Report Date
    November 4, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    CKB
    PMA / PMN Number
    K981743
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO MULTIPLE ERRONEOUS RESULTS GENERATED BY THE AU400 WHEN COMPARED TO AN ALTERNATE AU ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. PATIENT RESULTS WERE REQUESTED, HOWEVER THEY WERE NOT PROVIDED. PER CUSTOMER, THE ANALYZER GOT MULTIPLE CLOT DETECT ERRORS AND MULTIPLE TESTS WERE UNABLE TO CALIBRATE. ON THE DAY OF THE EVENT, A FIELD SERVICE ENGINEER (FSE) FOUND INTERNAL PROBE WASH IS FAILING AND ORDER A REPLACEMENT. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. SYSTEM VALIDATION DOCUMENTED IN CUSTOMER QC RECORD. ON (B)(4) 2011, THE FSE VERIFIED INSUFFICIENT INTERNAL SAMPLE AND REAGENT PROBE WASH. USING THE UNUSED AU400 IN THE MPLS CARDIO LAB FOUND THE DEGASSER TO BE LIMITING THE FLOW TO THE INTERNAL PROBE WASH. PROBLEM RESOLVED. VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED SPECIFICATIONS. SYSTEM VALIDATION DOCUMENTED IN CUSTOMER QC RECORD. THE ROOT CAUSE FOR THIS EVENT IS THE INTERNAL PROBE WASH IS FAILING BECAUSE DEGASSER IS LIMITING THE FLOW TO THE INTERNAL PROBE WASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU400 CLINICAL CHEMISTRY ANALYZER ACID PHOSPHATASE, NAPHTHYL PHOSPHATE CKB BECKMAN COULTER MISHIMA K.K. AU403-02E N/A

    Patients

    Seq Age Sex Outcome Treatment
    1