BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172257 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-02025
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Report Date
    December 4, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT PERFORMANCE, AND CALIBRATION AND SYSTEM CHECKS WERE WITHIN SPEC. THE PATIENT HAD CREATINE KINASE (CK) VALUE WITHIN THE NORMAL REFERENCE RANGE AND MYOGLOBIN OF 9.07 NG/ML. SAMPLE COLLECTION INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION PRIOR TO THE EVENT. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDRS: 2122870-2011-02013, 02014,020215, 02017, 02019, 02020, 02021, 02022, 02023, 02024, 02026. 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 PATIENTS 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 PATIENT SAMPLES. IN ADDITION, ELEVATED TROPONIN-I LEVELS HAVE ALSO BEEN DOCUMENTED IN CASES IN OTHER CARDIAC CONDITIONS SUCH AS UNSTABLE ANGINA, CONGESTIVE HEART FAILURE, OR MYOCARDITIS, OR SEVERE NON-CARDIAC CONDITIONS SUCH AS TRAUMA OR RENAL FAILURE THAT MAY CAUSE CARDIAC MUSCLE INJURY. THUS, TROPONIN (ACCUTNI) RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFORMATION. MEDICAL DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCUTNI DETERMINATION AT ONE TIME POINT.

    Description of Event or Problem · 1

    THE AFFILIATE ALLEGED THE CUSTOMER REPORTED ELEVATED TROPONIN-I (ACCUTNI) RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF ON ONE PATIENT'S SAMPLES INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THIS REPORT REFERS TO UNIT SERIAL NUMBER (B)(4). REPORT NUMBER ELEVEN OF TWELVE. THE RESULTS WERE DISCORDANT TO AN ALTERNATE METHODOLOGY THAT PRODUCED A NEGATIVE RESULT. THE LAST PATIENT SAMPLE WAS RETESTED IN 1:2 MOUSE ANTIBODIES DILUTION AND PRODUCED 1.14 NG/ML. THE ELEVATED RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY. IT IS UNKNOWN IF A CHANGE IN PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THE CUSTOMER PLANNED TO SUPPLY BECKMAN COULTER, INC. WITH THE PATIENT SAMPLE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR ACCESS ACCUTNI