BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1810526 · Received August 20, 2010

    Report

    Report Number
    2122870-2010-00457
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE DRAWN IN PLASTIC BD LIHEP PLASMA TUBES WITHOUT A GEL SEPARATOR AND CENTRIFUGED FOR 7 MINUTES AT 3300 RPM IN A SWINGING BUCKET CENTRIFUGE. QC RUN BEFORE AND AFTER THE EVENT WAS IN PASSING RANGE. THE SAMPLES WERE SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) AND TESTING CONFIRMED THE ROOT CAUSE TO BE PATIENT SOURCED HETEROPHILE INTERFERENCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ELEVATED TROPONIN (ACCUTNI) GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. FOUR SAMPLES WERE DRAWN FROM THE PATIENT AND GAVE RESULTS IN THE RANGE OF 1.01-1.21NG/ML. THE SAMPLES WERE TESTED ON 2 ALTERNATE METHODOLOGIES AND THE RESULTS WERE IN THE RANGE OF 0.00-0.01NG/ML ON THE FIRST ONE AND 0.01-0.06NG/ML ON THE SECOND. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1