BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1408821 · Received July 2, 2009

    Report

    Report Number
    1415939-2009-01068
    Event Type
    Malfunction
    Date Received
    July 2, 2009
    Date of Event
    June 17, 2009
    Report Date
    June 18, 2009
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 INVESTIGATION INCLUDED A REVIEW OF TRACKING AND TRENDING RECORDS, CUSTOMER DATA REVIEW, AND HISTORICAL DATA REVIEW. A REVIEW OF THE CAUSATIVE AGENT'S QUALITY RECORDS DID NOT IDENTIFY A TREND RELATED TO THE ISSUE UNDER INVESTIGATION. NO ISSUES WERE IDENTIFIED RELATED TO THE COMPLAINT THAT WOULD INDICATE THAT THERE IS A PRODUCT DEFICIENCY. TESTING OF FILE KITS OF ARCHITECT STAT TROPONIN-I REAGENT, LN 2K41-23, LOT 29489UN09 AND ARCHITECT STAT TROPONIN-I PANEL 1, LN 2K41P1-95, LOT V21883.VALIDITY CRITERIA MET. ACCEPTANCE CRITERIA MET; ALL PANEL REPLICATES WERE WITHIN THE SPECIFICATION RANGE OF 0.22-0.42 NG/ML.IN CONCLUSION, BASED UPON THE RESULTS OF THIS INVESTIGATION, THE ARCHITECT STAT TROPONIN-I REAGENT, LN 2K41-23, LOT 29489UN09 IS PERFORMING ACCEPTABLY.THE CUSTOMER WAS REFERRED TO THE ARCHITECT STAT TROPONIN-I REAGENT PACKAGE INSERT (840549/R6). THE SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS SECTION INDICATES THE FOLLOWING: FOR SERUM SPECIMENS, ENSURE THAT COMPLETE CLOT FORMATION HAS TAKEN PLACE PRIOR TO CENTRIFUGATION. SOME SPECIMENS, ESPECIALLY THOSE FROM PATIENTS RECEIVING ANTICOAGULANT OR THROMBOLYTIC THERAPY, MAY EXHIBIT INCREASED CLOTTING TIMES. IF THE SPECIMEN IS CENTRIFUGED BEFORE COMPLETE CLOT FORMATION, THE PRESENCE OF FIBRIN MAY CAUSE ERRONEOUS RESULTS. ADDITIONALLY, PER THE LIMITATIONS OF THE PROCEDURE SECTION: CARDIAC TROPONIN-I LEVELS CAN BE INCREASED IN ANY CONDITION RESULTING IN CARDIAC CELL DAMAGE. FOR MI 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.THE INVESTIGATION DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES OR ADDITIONAL ISSUES.THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT WHEN ATTEMPTING TO PROCESS A PATIENT SAMPLE ON THE ARCHITECT ANALYZER SERIAL NO. FOR THE STAT TROPONIN-I ASSAY THAT AN ERROR CODE 3350 WAS GENERATED, UNABLE TO PROCESS TEST DUE TO ASPIRATION ERROR. THE SERUM SAMPLE HAD RE-COAGULATED AND WAS THEN CENTRIFUGED AGAIN AND PROCESSED ON ANOTHER ARCHITECT ANALYZER, SERIAL NO. GENERATING A TROPONIN-I RESULT OF 0.504 NG/ML (A POTENTIAL FALSE POSITIVE). A SECOND DRAWN SPECIMEN FOR THIS PATIENT HAD GENERATED TROPONIN-I RESULTS ON BOTH INSTRUMENTS BELOW THE DETECTION LIMIT OF <0.01 NG/ML. THE FIRST DRAWN SPECIMEN WAS REPEATED ON BOTH ARCHITECT ANALYZERS GENERATING THE FOLLOWING RESULTS: 0.026 NG/ML AND 0.018 NG/ML. THE CUSTOMER USES A CUTOFF VALUE OF 0.1 NG/ML IN DETERMINING POSSIBLE MYOCARDIAL INFARCTION. NO SUSPECT RESULTS WERE NOT REPORTED FROM THE LAB AND THERE WAS NO ADVERSE OUTCOMES REPORTED FOR THIS ISSUE.

    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 45 YR ARCHITECT ANALYZER