BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2484431 · Received March 8, 2012

    Report

    Report Number
    2122870-2012-00599
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LFX
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PERFORMANCE DATA INDICATED THAT AN EXECUTED (B)(6) 2012 CALIBRATION'S S0 CALIBRATOR RELATIVE LIGHT UNITS (RLUS) WERE SIGNIFICANTLY HIGHER THAN BECKMAN COULTER INC. IN HOUSE RELEASE. THIS CALIBRATION WAS THE ACTIVE CALIBRATION DURING THE EVENT WHICH GENEATED THE LOW LEVEL QC IND RESULTS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT PREVIOUS AND SUBSEQUENT CALIBRATIONS GENERATED ACCEPTABLE RESULTS WITH ACCEPTABLE COEFFICIENTS OF VARIATION, GOOD PRECISION AND S0 STANDARD RLUS BOTH BELOW AND ABOVE BECKMAN COULTER INC. IN HOUSE RELEASE DATA RESPECTIVELY. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT QUALITY CONTROL ASSESSMENTS WERE PERFORMED ON EACH DAY DURING THE TIMEFRAME OF THE EVENT. ALL QC VALUES WERE WITHIN TWO STANDARD DEVIATIONS OF THE CUSTOMER'S ESTABLISHED MEANS. A ROUTINE SYSTEM CHECK PERFORMED PRIOR TO THE EVENT FAILED TO MEET INSTRUMENT SPECIFICATIONS DUE TO AN ELEVATED UNWASHED PERCENT COEFFICIENT OF VARIATION. BECKMAN COULTER INC. ADVISED THE CUSTOMER TO PERFORM A ROUTINE SYSTEM CHECK WHICH PASSED WITHIN THE INSTRUMENT'S SPECIFICATIONS. THERE WERE NO ERRORS POSTED TO THE EVENT LOG IN CONJUNCTION WITH THIS EVENT. THE CAUSE OF THIS EVENT IS UNKNOWN AND COULD NOT BE DETERMINED BASED ON THE SUPPLIED INFORMATION

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2012 NO VALUE RUBELLA IMMUNOGLOBULIN G (IGG) LOW LEVEL QUALITY CONTROL RESULTS WITH INSTRUMENT GENERATED FLAGS WERE GENERATED ON AN UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM. THE INSTRUMENT GENERATED FLAG WAS AN INDETERMINATE FLAG WHICH IS INDICATIVE OF A RESULT THAT CANNOT BE DISTINGUISHED FROM A SYSTEM FAILURE. . THERE WERE NO PATIENT RESULTS REPORTED OUTSIDE OF THE LABORATORY IN ASSOCIATION WITH THIS EVENT. THERE HAVE BEEN NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY LFX BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS RUBELLA IGG REAGENT AND CALIBRATOR