BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2160275 · Received June 2, 2011

    Report

    Report Number
    2122870-2011-01613
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    July 30, 2007
    Report Date
    July 30, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE ISSUE WAS ISOLATED TO ONE PATIENT AND RESULTS WERE ABLE TO BE REPRODUCED. THE CUSTOMER STATED TROPONIN RESULTS WERE ELEVATED BUT DID NOT PROVIDE EXACT VALUES. THE CUSTOMER REPORTED VALUES OBTAINED WERE NEAR 27 NG/ML. THE CUSTOMER STATED, THE SAMPLES FROM THIS PATIENT WERE TESTED AND WERE NEGATIVE ON THE ISTAT AND CENTAUR METHODS. SAMPLE HANDLING DETAILS AND QUALITY CONTROL (QC) DATA WERE NOT SUPPLIED. THE CUSTOMER PROVIDED SAMPLES TO BECKMAN COULTER, INC. FOR FURTHER INVESTIGATION CONSISTING OF ONE SERUM, TWO PLASMA, AND ONE WHOLE BLOOD SPECIMEN. THE SERUM AND PLASMA SAMPLES WERE TESTED IN THE CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY. CPLS TESTED THE SAMPLES NEAT AND REPRODUCED THE ELEVATED VALUES. FURTHERMORE, THE ADDITION OF HETEROPHILE BLOCKING AGENTS SIGNIFICANTLY REDUCED THE TROPONIN CONCENTRATION, WHICH CONFIRMS HETEROPHILE INTERFERENCE IS THE ROOT CAUSE FOR THE ERRONEOUS, FALSE POSITIVE TROPONIN RESULTS. 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)(6) 2008 TO (B)(6), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN (ACCUTNI) PATIENT RESULTS INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. RESULTS WERE REPEATEDLY ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF AND NEGATIVE BY TWO ADDITIONAL METHODS. THE CUSTOMER TESTED THIS PATIENT SAMPLE ON THE DXI AND ACCESS 2 SYSTEMS AS WELL AS ON ANOTHER ACCESS 2 UNIT AT THE HOSPITAL SITE WHERE THE PATIENT WAS LOCATED. THE CUSTOMER HAD ALSO SENT OUT SAMPLES TO BE TESTED BY A THIRD LABORATORY THAT USES A CENTAUR SYSTEM, AND THE PATIENT RESULTS CAME BACK NORMAL. THE CUSTOMER NOTED, THE PATIENT HAD A NORMAL ELECTROCARDIOGRAM (ECG). THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT WAS NOTED THAT THERE WAS A CHANGE IN PATIENT TREATMENT BUT THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ATTRIBUTED WITH THIS EVENT.

    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 UNK ACCESS 2 IMMUNOASSAY SYSTEM| ACCUTNI ON THE ACCESS IMMUNOASSAY SYSTEMS