BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2194224 · Received August 6, 2011

    Report

    Report Number
    2122870-2011-02775
    Event Type
    Malfunction
    Date Received
    August 6, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS LITHIUM HEPARIN PLASMA THAT WAS ORIGINALLY CENTRIFUGED FOR 7 MINUTES AT 3850RPM. PER CUSTOMER, THE SAMPLE LOOKED CLEAR AND THERE WERE NO NOTED ISSUES WITH THE SAMPLE QUALITY. QC IS PERFORMED ONCE DAILY AND WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THIS EVENT. THE CUSTOMER PERFORMED A SYSTEM CHECK AND A 10 POINT PRECISION RUN AFTER THE ERRONEOUS RESULTS ABOVE AND BOTH MET SPECIFICATIONS. THE CUSTOMER DECLINED SERVICE AS ONLY ONE PATIENT SAMPLE WAS IN QUESTION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING CREATINE KINASE-MB (CKMB) RESULTS GENERATED BY THE UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. THE PATIENT'S INITIAL CKMB RESULT WAS 67.1NG/ML (TOTAL CK RESULT WAS 68NG/ML AND THE PATIENT'S PREVIOUS TOTAL CK RESULT WAS 63NG/ML.) THE CUSTOMER QUESTIONED THE RESULT AND DID NOT REPORT IT OUTSIDE OF THE LABORATORY. THE SAMPLE WAS POURED OFF AND REPEAT TESTING WAS PERFORMED. THE REPEAT CKMB RESULT WAS 68.8NG/ML AND TOTAL CK RESULT WAS 55NG/ML. THE SAMPLE WAS THEN CENTRIFUGED FOR 3 MINUTES AND THE REPEAT CKMB RESULT WAS 4.7NG/ML ON THIS INSTRUMENT AND 3.7NG/ML ON AN ALTERNATE INSTRUMENT. NO REPORTS OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT HAVE BEEN ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1