BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172105 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01784
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    August 30, 2007
    Report Date
    August 30, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF SERVICE WAS SENT ON SITE. SAMPLES HANDLING INFORMATION WAS NOT PROVIDED. QUALITY CONTROL (QC) INFORMATION WAS NOT SUPPLIED. SYSTEM CHECK INFORMATION FROM (B)(6) 2007 WAS PROVIDED AND MET SPECIFICATION. CURRENT SYSTEM CHECK INFORMATION WAS NOT PROVIDED. TWO SAMPLES FROM THE SAME PATIENT WERE RECEIVED FOR INVESTIGATION. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY REPEATED THE CUSTOMER'S RESULT ON NEAT SAMPLE, AND OBTAINED - FOR EACH TUBE - HIGH VALUES OF TROPONIN. HETEROPHILE TESTING INDICATED INTERFERENCE WAS NOT OF A HETEROPHILE TYPE. BOTH SAMPLES BEHAVED THE SAME. TAKING ACCOUNT OF THE HETEROPHILE TESTING RESULTS, DILUTION TEST WAS PERFORMED IN HUMAN SERUM TO AVOID SAMPLE PRECIPITATION. EVEN UNDER THESE CONDITIONS, DILUTION TEST RECOVERIES WERE LOW AND ERRATIC CONFIRMING THE INTERFERENCE. THEREFORE, IT IS CONCLUSIVE THAT THE CUSTOMER'S RESULTS WERE FALSELY ELEVATED BECAUSE OF EVIDENT INTERFERING SUBSTANCES IN PATIENT BLOOD. 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. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 THROUGH (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE AFFILIATE ALLEGED, THE CUSTOMER REPORTED ELEVATED TROPONIN (ACCUTNI) PATIENT RESULT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT CORRELATE WITH CLINICAL CONDITION OF THE PATIENT. ELECTROCARDIOGRAM (ECG) WAS PERFORMED WITH NORMAL FINDINGS. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SENT THE PATIENT SAMPLE TO BECKMAN COULTER, INC FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR ACCESS ACCUTNI