BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRON LX 725 SYSTEM

    MDR report key: 2245578 · Received September 2, 2011

    Report

    Report Number
    2050012-2011-04884
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    October 8, 2008
    Report Date
    October 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CUSTOMER COLLECTED SAMPLES IN GREEN TOP GEL TUBES. TROPONIN I QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2008, WAS WITHIN SPECIFICATIONS. TESTING AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY CONFIRMED THE EXISTENCE OF A PT SOURCE INTERFERENT FOR THE PT'S 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 POSSIBILITY EXISTS FOR INTERFERENCE BY HUMAN ANTI-MOUSE ANTIBODIES (HAMA) IN THE SAMPLE. HUMAN ANTI-MOUSE ANTIBODIES MAY BE PRESENT IN SAMPLES FROM PTS 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-GOAT ANTIBODIES, MAY BE PRESENT IN PT SAMPLES. THE ACCESS ACCUTNI AND ACCESS CK-MB RESULTS SHOULD BE INTERPRETED IN 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. (B)(4). THIS MEDWATCH REPORT IS RELATED TO MDR 2050012-2011-04883.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCUTNI) AND CREATINE KINASE-MB (CK-MB) RESULTS, FOR ONE PATIENT ON MULTIPLE SAMPLES INVOLVING SYNCHRON LX 725 SYSTEM. THIS IS REPORT NUMBER TWO OF TWO REFERENCING SYSTEM (B)(4). THE TROPONIN I RESULTS RECOVERED WITHIN THE RISK STRATIFICATION RANGE, AND THE CK-MB RESULTS RECOVERED ABOVE THE REFERENCE RANGE. THE ELEVATED RESULTS WERE DISCORDANT TO AN ALTERNATE METHODOLOGY, WHICH WAS NEGATIVE, AND DID NOT CORRELATE WITH THE PT'S CLINICAL CONDITION. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE PT UNDERWENT HEART CATHETERIZATION AND WAS LATER DISCHARGED. ALL OTHER TESTS PERFORMED WERE NORMAL. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. WITH THE PT SAMPLES FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 725 SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R ACCESS CK-MB| ACCESS ACCUTNI