BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 2537553 · Received April 17, 2012

    Report

    Report Number
    1415939-2012-00142
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Report Date
    March 22, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARCHITECT STAT TROPONIN-I ASSAY PERFORMANCE WAS EVALUATED IN REGARDS TO ACCURACY BY TESTING AN INTERNAL TROPONIN-I PANEL WITH REAGENT LOT 91925UN11. ALL RESULTS WERE WITHIN SPECIFICATION, VERIFYING THE ACCURACY OF THE ASSAY TO DETECT KNOWN CONCENTRATIONS OF TROPONIN-I. ASSAY PRECISION WAS EVALUATED BY RUNNING LOW, MEDIUM AND HIGH ARCHITECT STAT TROPONIN-I CONTROLS IN REPLICATES OF FOUR, TWICE PER DAY, OVER A FIVE DAY PERIOD. THE RESULTS OF THE MEDIUM AND HIGH CONTROLS MET THE ASSAY PACKAGE INSERT (840653/R08) SPECIFICATIONS FOR THE MAXIMUM ALLOWABLE LIMIT FOR THE COEFFICIENT OF VARIATION OF LESS THAN OR EQUAL TO 10% FOR SAMPLES GREATER THAN OR EQUAL TO 0.20 NG/ML. THE LOW CONTROL RANGED FROM 0.14 TO 0.17 NG/ML AND ALSO MET ASSAY PACKAGE INSERT SPECIFICATIONS. THE EVALUATION ALSO CONSISTED OF A REVIEW OF CUSTOMER COMPLAINTS RECEIVED TO-DATE TO DETERMINE IF OTHERS HAVE EXPERIENCED THE ISSUE ENCOUNTERED BY THIS CUSTOMER. THE REVIEW OF THIS DATA DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. NON-STATISTICAL TRENDS WERE IDENTIFIED DURING THE COMPLAINT TREND REVIEW RELATED TO DISCREPANT PATIENT RESULTS. ADDITIONALLY, MONTHLY COMPLAINT TRACKING AND TRENDING FOR LIST 2K41 DID NOT IDENTIFY ANY ADVERSE TRENDS DUE TO LOT 91925UN11. THE PRECISION AND ACCURACY TESTING PERFORMED USING THE LIKELY CAUSE LOT NUMBER MET ACCEPTANCE CRITERIA, WHICH INDICATE ACCEPTABLE PRODUCT PERFORMANCE. NO ADDITIONAL ISSUES WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT EVALUATION. BASED ON THE RESULTS OF THIS CURRENT INVESTIGATION, THE ARCHITECT STAT TROPONIN-I ASSAY LOT 91925UN11 IS PERFORMING ACCEPTABLY. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED. (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE POSITIVE RESULTS GENERATED ON A PATIENT SAMPLE WHILE TESTING WITH THE ARCHITECT STAT TROPONIN-I ASSAY. INITIAL RESULTS OF 0.0 AND 0.003 NG/ML WERE GENERATED WITH REAGENT LOT 14543UN11. THE SAMPLE WAS THEN RETESTED ON ARCHITECT I2000SR ANALYZER SERIAL NUMBER (B)(4) IN THE CUSTOMER'S LAB AND GENERATED A POSITIVE RESULT OF 0.052 NG/ML USING REAGENT LOT 91925UN11, WHICH WAS REPORTED FROM THE LAB. THE CUSTOMER USES A CUT-OFF VALUE OF 0.03 NG/ML. THERE IS NO KNOWN PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 91925UN11

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN: 03M74-02 SN: (B)(4)