BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 2780263 · Received October 10, 2012

    Report

    Report Number
    1415939-2012-02036
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. AN ACCURACY TESTING PROTOCOL WAS EXECUTED USING LOT 60232UN12; TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR THE LOT IN QUESTION. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT STAT TROPONIN-I REAGENT LIST NUMBER 02K41, LOT NUMBER 60232UN12, WAS IDENTIFIED.

    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 OBSERVED DISCREPANT TROPONIN RESULTS FOR 1 PATIENT WHILE USING THE ARCHITECT STAT TROPONIN-I ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (UG/ML): FIRST SPECIMEN (SID (B)(4)) (TIME 6:27 AM) INITIAL RESULT 0.004 NG/ML; SECOND SPECIMEN (SID (B)(4)) (2:00 PM) 1.092 NG/ML, RETESTED: 1.128 NG/ML. THE FIRST SPECIMEN WAS TESTED AGAIN AND GENERATED A RESULT OF 0.185 NG/ML. IT WAS RE-RUN AGAIN AND GENERATED A RESULT OF 0.004 NG/ML. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 60232UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| ARCHITECT I2000SR ANALYZER| LN 03M74-02, SN (B)(4)| LN 03M74-02, SN ISR50282