BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1398453 · Received June 5, 2009

    Report

    Report Number
    1415939-2009-01006
    Event Type
    Injury
    Date Received
    June 5, 2009
    Date of Event
    May 5, 2009
    Report Date
    May 13, 2009
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: A REVIEW OF THE COMPLAINT DATA WAS PERFORMED TO ASSESS THE PERFORMANCE OF THE ASSAY. THE COMPLAINT ACTIVITY WAS NORMAL FOR THE ISSUE UNDER INVESTIGATION. THE ISSUE OBSERVED BY THE CUSTOMER IS ADEQUATELY ADDRESSED IN THE PRODUCT LABELING. WE REVIEWED CUSTOMER COMPLAINTS RECEIVED TO-DATE TO DETERMINE IF OTHERS HAVE EXPERIENCED THIS SAME ISSUE. OUR REVIEW OF THESE DATA DID NOT IDENTIFY AN INCREASE IN THE NUMBER OF COMPLAINTS RELATED TO DISCREPANT RESULTS FOR THE ARCHITECT STAT TROPONIN-I ASSAY. WE WOULD LIKE TO TAKE THIS OPPORTUNITY TO REFER THE CUSTOMER TO THE LIMITATIONS OF THE PROCEDURE SECTION IN THE ARCHITECT STAT TROPONIN-I PACKAGE INSERT (840549/R6). THIS SECTION STATES THAT SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF MOUSE MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-MOUSE ANTIBODIES (HAMA). SUCH SPECIMENS MAY SHOW EITHER FALSELY ELEVATED OR DEPRESSED VALUES WHEN TESTED WITH ASSAY KITS WHICH EMPLOY MOUSE MONOCLONAL ANTIBODIES. ADDITIONAL CLINICAL OR DIAGNOSTIC INFORMATION MAY BE REQUIRED TO DETERMINE PATIENT STATUS. ADDITIONALLY, HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. THE PRESENCE OF HETEROPHILIC ANTIBODIES IN A PATIENT SPECIMEN MAY CAUSE ANOMALOUS VALUES TO BE OBSERVED. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS. FOR MYOCARDIAL INFARCTION DIAGNOSTIC PURPOSES, THE ARCHITECT STAT TROPONIN-I RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER INFORMATION, SUCH AS CARDIAC MARKER RESULTS (E.G., CK-MB AND/OR MYOGLOBIN), ECG, CLINICAL OBSERVATIONS AND SYMPTOMS, ETC. BASED ON OUR INVESTIGATION, WE CONCLUDE THAT THE ARCHITECT STAT TROPONIN-I ASSAY IS PERFORMING AS INTENDED, AND IS MEETING ITS SAFETY, EFFECTIVENESS, AND LABEL CLAIMS. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT TROPONIN REAGENT HAS GENERATED FALSE POSITIVE RESULTS. IN 2009, THE RESULT WAS 34.26 NG/ML. TWO DAYS LATER, THE RESULT WAS 30.05 NG/ML.THE NEXT DAY, THE RESULT WAS 30.95 NG/ML AND THE FOLLOWING DAY, THE RESULT WAS 27.40 NG/ML. THE BNP RESULT WAS <16 AND THE MYOGLOBIN RESULT WAS NORMAL. THE PATIENT WAS HOSPITALIZED AND RETESTED BY THE ACCESS TECHNIQUE AND THE TROPONIN RESULT WAS NEGATIVE. THREE DAYS LATER, THE ACCOUNT REDREW A NEW SAMPLE FROM THE PATIENT, THE TROPONIN RESULTS WERE REACTIVE ( 27.4 NG/ML, THE 1:3 DILUTION WAS 102 AND THE 1:10 DILUTION WAS 110 NG/ML). THE ACCOUNT STATED THAT THE PATIENT HAD AN UNNECESSARY CORONARY ANGIOGRAPH DUE TO A FALSE POSITIVE TROPONIN RESULT. THE DOCTORS HAVE NOT BEEN ABLE TO DIAGNOSE THIS PATIENT AS THIS PATIENT IS HOSPITALIZED IN ANOTHER HOSPITAL. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I FOR THE DETERMINATION OF CARDIAC TROPONIN-I IN HUMAN SERUM OR PLASMA MMI ABBOTT LABORATORIES 29489UN09

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S ARCHITECT