BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 2772403 · Received October 4, 2012

    Report

    Report Number
    1415939-2012-02030
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP WILL BE SUBMITTED WHEN PRODUCT EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. REVIEW OF TICKET TRENDING AND LOT SEARCH DATA IDENTIFIED ATYPICAL COMPLAINT ACTIVITY RELATED TO DISCREPANT PATIENT RESULTS. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 21173UN11. ACCEPTANCE CRITERIA WERE MET, WHICH INDICATED ACCEPTABLE PRODUCT PERFORMANCE. A DEFICIENCY WAS NOT IDENTIFIED AS PANEL TESTING SHOWS THAT THE LIKELY CAUSE LOT PERFORMS PER SPECIFICATION AND NO MALFUNCTION WAS IDENTIFIED SINCE QUALITY CONTROL WAS WITHIN RANGE AND THERE IS NO INDICATION FOR THE CAUSE FOR THE RESULT OBTAINED WITH NO FURTHER TROUBLE SHOOTING PERFORMED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT LOT NUMBER IS ADDED. PRODUCT EVALUATION RESULTS WILL BE SUBMITTED IN ANOTHER FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT FELL AT HOME AND WAS BROUGHT TO THE EMERGENCY DEPARTMENT. A BLOOD SAMPLE FROM THIS PATIENT GENERATED A POSITIVE RESULT FOR THE ARCHITECT TROPONIN ASSAY (0.7 NG/ML). HOWEVER, THERE WAS NO ISSUE WITH THE PATIENT'S HEART. THE PATIENT WAS ADMINISTERED DEMENTIA DRUGS (NO INFORMATION WAS PROVIDED REGARDING THE TIME OF ADMINISTRATING THE DRUGS, BEFORE OR AFTER THE POSITIVE TROPONIN RESULT). THE POSITIVE RESULT WAS REPORTED OUT AND QUESTIONED (INQUIRED ABOUT SITUATIONS THAT COULD INCREASE THE TROPONIN LEVELS OTHER THAN THE CARDIAC ISSUES). NO IMPACT TO PATIENT HEALTH WAS REPORTED. THE CUSTOMER CLAIMED THE POSITIVE TROPONIN RESULT AS FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 21173UN11

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 ANALYZER: 3M74-01 SN (B)(4)| ARCHITECT I2000 ANALYZER: 3M74-01 SN (B)(4)| ARCHITECT I2000 ANALYZER: 3M74-01 SN (B)(4)