BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1884375 · Received October 27, 2010

    Report

    Report Number
    2122870-2010-00672
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 27, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A GREINER VACUETTE LI-HEP PLASMA TUBE AND CENTRIFUGED FOR 10 MINUTES AT 3000G AT 20º C. SAMPLE WAS IN AN ALIQUOT TUBE FOR INITIAL RUN AND FIRST RERUN AND WAS RE-CENTRIFUGED BEFORE RETESTING AGAIN. QC IS RECOVERING WITHIN ESTABLISHED RANGES. PER CUSTOMER, THERE ARE NO 'INSTRUMENT ISSUES' AND SERVICE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. UPON RE-CENTRIFUGATION, THE SAMPLE WAS RERUN AND RESULTS WERE IN THE NORMAL REFERENCE RANGE. 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 53 YR