BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1781561 · Received August 3, 2010

    Report

    Report Number
    2122870-2010-00388
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JHS
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS LI HEPARIN PLASMA COLLECTED IN A PST TUBE AND CENTRIFUGED FOR 5 MINUTES AT 6000 RPM. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED ON 06/14/2010 MET SPECIFICATIONS. PER CUSTOMER, THIS SAMPLE COLLECTION TUBE WAS ONLY 2/3 OF THE RECOMMENDED FILL VOLUME. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED SOME HARDWARE AFTER WHICH A SYSTEM CHECK, PRECISION RUN AND QC PERFORMED ALL MET SPECIFICATIONS. ALTHOUGH A SAMPLE ISSUE MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A CKMB RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. UPON REPEAT, THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1