BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2258803 · Received September 2, 2011

    Report

    Report Number
    2050012-2011-04890
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    November 5, 2008
    Report Date
    November 5, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE SPECIMEN WAS COLLECTED BY PHLEBOTOMIST IN A PLASTIC LITHIUM HEPARIN WITHOUT GEL TUBE. THE TUBE WAS INVERTED PER THE MANUFACTURER'S INSTRUCTIONS. THE SPECIMEN WAS CENTRIFUGED AT 5,000 RPM (ROTATION PER MINUTE) FOR GREATER THAN 5 MINUTES. TESTING AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY CONFIRMED THE EXISTENCE OF A PATIENT SOURCE INTERFERENT FOR THE SAMPLE RECEIVED FROM THE CUSTOMER. THE INTERFERENCE LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND CAUSES REPRODUCIBLE FALSE POSITIVE RESULTS, BUT IS DISTINCT FROM HETEROPHILE ANTIBODIES. PRODUCT LABELING: FOR ASSAYS EMPLOYING MOUSE ANTIBODIES, THE POSSIBLE EXISTS FOR INTERFERENCE BY HUMAN ANTI-MOUSE ANTIBODIES (HAMA) IN THE SAMPLE. HUMAN ANTI-MOUSE ANTIBODIES MAY BE PRESENT IN SAMPLES FROM PT WHO HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING MONOCLONAL ANTIBODIES OR IN INDIVIDUALS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES, SUCH AS HUMAN ANTI-GOAD ANTIBODIES, MAY BE PRESENT IN PT SAMPLES. THE ACCESS ACCUTNI RESULTS SHOULD BE INTERPRETED I LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFO. MEDICAL DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCUTNI DETERMINATION AT ONE TIME POINT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINS CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDR 2050012-2011-05103.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REPRODUCIBLE ELEVATED TROPONIN I (ACCUTNI) RESULTS FOR ONE PT INVOLVING UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THIS IS REPORTED NUMBER ONE OF TWO REFERENCING SYSTEM SERIAL NUMBER (B)(4). THE CUSTOMER PERFORMED DILUTIONS AND RECOVERED NON-LINEAR RESULTS. THE ELEVATED RESULTS WERE DISCORDANT TO AN ALTERNATE METHODOLOGY, WHICH PRODUCED A NEGATIVE RESULT. THE ELEVATED RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. WITH THE PT SAMPLE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR ACCESS ACCUTNI