BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 3894051 · Received June 25, 2014

    Report

    Report Number
    1415939-2014-00135
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SIZE CODE WAS CHANGED. REVIEW OF TICKET TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 60820UN14. ACCEPTANCE CRITERIA WAS MET WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. A DEFICIENCY WAS NOT IDENTIFIED AS PANEL TESTING SHOWS THAT THE LIKELY CAUSE LOT PERFORMS PER SPECIFICATION. THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION SINCE THE ISSUE INVOLVES A DISCREET SAMPLE. RETEST OF THE ORIGINAL SAMPLE ON THE ORIGINAL INSTRUMENT AS WELL AS ANOTHER ARCHITECT GENERATED NEGATIVE RESULTS. PER THE COMPLAINT TEXT THE FIELD SERVICE REPRESENTATIVE OBSERVED THE SAMPLE WAS HEMOLYZED, WHICH LEADS TO THE POSSIBILITY THAT SAMPLE INTEGRITY MAY HAVE CONTRIBUTED TO THE ELEVATED RESULT. ADDITIONALLY, THE SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS SECTION OF THE ARCHITECT STAT TROPONIN-I PACKAGE INSERT PROVIDES EXAMPLES OF SITUATIONS THAT MAY CAUSE ERRONEOUS RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED A FALSELY ELEVATED TROPONIN RESULT ON ONE PATIENT SAMPLE. THE RESULTS PROVIDED WERE: INITIAL 0.094 / 0.012NG/ML. THE SAMPLE WAS ASSAYED ON ANOTHER ARCHITECT AND GENERATED RESULTS OF 0.009 / 0.000 / 0.006 / 0.000NG/ML. THE CUSTOMER'S DIAGNOSTIC CUTOFF FOR TROPONIN IS 0.090 NG/ML. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED ADVERSE IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371930 ARCHITECT STAT TROPONIN-I TROPONIN-I MMI ABBOTT LABORATORIES 60820UN14

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,| ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,| SERIAL # (B)(4)| SERIAL # (B)(4)