BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL¿ DXL800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2484387 · Received March 8, 2012

    Report

    Report Number
    2122870-2012-00598
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 16, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LFX
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 A PREVIOUSLY EXECUTED ((B)(4) 2012) AND ACCEPTED CALIBRATION'S S0 CALIBRATOR RELATIVE LIGHT UNITS (RLUS) WERE HIGHER THAN BECKMAN COULTER INC. IN HOUSE RELEASE, AS WELL AS THE RLUS ASSOCIATED WITH THE (B)(4) 2012, QC RESULTS. 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 PASSED WITHIN THE INSTRUMENT'S SPECIFICATIONS. THE CAUSE OF THIS EVENT IS UNKNOWN AND COULD NOT BE DETERMINED BASED ON THE SUPPLIED INFORMATION ASSOCIATED MDRS: 2122870-2012-00597, 2122870-2012-00598.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT NO VALUE RUBELLA IMMUNOGLOBULIN G (IGG) LOW LEVEL QUALITY CONTROL RESULTS WITH INSTRUMENT GENERATED FLAGS WERE GENERATED ON AN UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ON TWO DAYS. THIS REPORT REPRESENTS THE NO VALUE RUBELLA IMMUNOGLOBULIN G (IGG) QUALITY CONTROL RESULTS GENERATED ON (B)(6) 2012. 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 GENERATED IN CONNECTION TO 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¿ DXL800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY LFX BECKMAN COULTER, INC. NA NA

    Patients

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