BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 3904933 · Received July 1, 2014

    Report

    Report Number
    1415939-2014-00140
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW FOR SIMILAR COMPLAINTS, ACCURACY TESTING, AND A REVIEW OF LABELING. THE CUSTOMER OBSERVED FALSELY ELEVATED AND INCONSISTENT PATIENT RESULT, WHILE USING ARCHITECT STAT TROPONIN-I, LIST 2K41-38, LOT 36932UN14. THERE WERE NO CUSTOMER RETURNS AVAILABLE. A REVIEW OF COMPLAINT TICKETS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO FALSELY ELEVATED PATIENT RESULTS. ACCURACY TESTING WAS COMPLETED USING A RETAINED KIT OF REAGENT LOT 36932UN14 AND ACCEPTANCE CRITERIA WERE MET. A DEFICIENCY WAS NOT IDENTIFIED AS PANEL TESTING SHOWS THAT LOT 36932UN14 IS PERFORMING PER SPECIFICATION. A REVIEW OF PRODUCT LABELING PROVIDES CONDITIONS THAT MAY CAUSE ERRONEOUS RESULTS. THERE WAS NO MALFUNCTION IDENTIFIED. NO ADDITIONAL ISSUES WERE IDENTIFIED; NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY ELEVATED TROPONIN RESULTS ON ONE PATIENT SAMPLE. RESULTS PROVIDED: INITIAL ON SERIAL NUMBER (SN) (B)(4) = 0.0 / REPEAT 242.48NG/L; SAMPLE RUN ON SN (B)(4) = 26.9NG/L; 3RD RUN ON SN (B)(4) =0.0NG/L. THE CUSTOMER'S DIAGNOSTIC CUTOFF FOR TROPONIN IS 32NG/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383750 ARCHITECT STAT TROPONIN-I TROPONIN-I MMI ABBOTT LABORATORIES 36932UN14

    Patients

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