BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2628003 · Received June 25, 2012

    Report

    Report Number
    2122870-2012-01508
    Event Type
    Injury
    Date Received
    June 25, 2012
    Date of Event
    June 2, 2012
    Report Date
    June 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT THE SAMPLE WAS NO ALLOWED TO CLOT FOR THE RECOMMENDED AMOUNT OF TIME PRIOR TO TESTING. COLLECTION TUBE MANUFACTURER LABELING STATES THAT TUBES SHOULD BE ALLOWED TO CLOT FOR THIRTY MINUTES TO ENSURE COMPLETE CLOT FORMATION PRIOR TO CENTRIFUGATION. USE ERROR VIA SUSPECT PRE-ANALYTICAL SAMPLE HANDLING IS THE LIKELY CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUS ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY, WAS GENERATED FROM A UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM FOR A SINGLE EMERGENCY ROOM PATIENT. THE LABORATORY TECHNICIAN DID NOT FOLLOW THE CUSTOMER'S INTERNAL POLICY TO REPEAT ELEVATED INITIAL ACCUTNI RESULTS AND REPORTED THE INITIAL ELEVATED RESULT FROM THE LABORATORY. THE PATIENT WAS ADMITTED TO THE HOSPITAL'S CRITICAL CARE UNIT BASED UPON THE INITIAL ELEVATED ACCUTNI RESULT. UPON SUBSEQUENT DUPLICATE REPEAT TESTING OF THE PATIENT SAMPLE, LOWER ACCUTNI RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY WERE GENERATED. A CORRECTED REPORT WAS ISSUED. THE PATIENT SAMPLE WAS A SERUM SAMPLE, WAS A FULL DRAW, AND WAS COLLECTED INTO A PRIMARY COLLECTION TUBE. THE SAMPLE WAS TESTED WITHIN FIFTEEN MINUTES OF COLLECTION. THE SAMPLE WAS CENTRIFUGED AT ROOM TEMPERATURE PRIOR TO TESTING. SPECIFIC PATIENT INFORMATION, AND INSTRUMENT PERFORMANCE INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. THE REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 122818 AND 120792 RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R