BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1271165 · Received December 26, 2008

    Report

    Report Number
    1415939-2008-00534
    Event Type
    Malfunction
    Date Received
    December 26, 2008
    Date of Event
    December 11, 2008
    Report Date
    December 19, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ARCHITECT I2000SR ANALYZER LN: 3M74-01. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER: 2K41-35 (SIZE CODE (35) CHANGE ONLY).TESTING WAS NOT PERFORMED FOR THIS INVESTIGATION; INSTEAD, THE QUALITY RECORDS WERE REVIEWED. 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.THE ARCHITECT STAT TROPONIN-I REAGENT KIT INSERT (COMMODITY 840549/R6, LIMITATIONS OF THE PROCEDURE AND SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS SECTIONS) STATES THAT 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. ABBOTT LABORATORIES RECOMMENDS THE USE OF HEPARINIZED PLASMA SPECIMENS FOR THE ARCHITECT STAT TROPONIN-I ASSAY. 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., CKMB AND/OR MYOGLOBIN), ECG, CLINICAL OBSERVATIONS AND SYMPTOMS, ETC. ADDITIONALLY, THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES TROUBLESHOOTING RESOURCES (SECTION 10) WHICH ADDRESS DISCREPANT/ERRATIC RESULTS.THE INVESTIGATION DEMONSTRATED THAT THE ARCHITECT STAT TROPONIN-I ASSAY IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ARCHITECT STAT TROPONIN-I ASSAY GENERATES INTERMITTENT ELEVATED PATIENT RESULTS THAT RETEST AT LOWER LEVELS. ONE PATIENT GENERATED AN INITIAL RESULT OF 0.048 UG/L THAT RETESTED AT 0.020 UG/L. THE CUSTOMER USES A CUT-OFF VALUE OF 0.030 UG/DL. THERE HAS BEEN NO REPORTED IMPACT TO PATIENT MANAGEMENT IN REGARDS TO 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 23256UN08

    Patients

    Seq Age Sex Outcome Treatment
    1