BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 3120576 · Received May 20, 2013

    Report

    Report Number
    1415939-2013-00213
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, ACCURACY TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE COMPLAINT TEXT INDICATED THAT CALIBRATOR LOT 060564 WAS UTILIZED TO CALIBRATE REAGENT LOT 84111UN13. CALIBRATOR LOT 060564 EXPIRED ON JANUARY 31, 2013 AND WAS USED PAST EXPIRATION. ADDITIONALLY, THE RESULT OF THE SUBSEQUENT SAMPLE AND RETEST OF THE ORIGINAL SAMPLE PRODUCED NEGATIVE RESULTS INDICATING A SAMPLE SPECIFIC ISSUE. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 84111UN13. ACCEPTANCE CRITERIA WAS MET. TRACKING AND TRENDING DID NOT IDENTIFY ANY ATYPICAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER REVIEW.. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED FALSELY ELEVATED TROPONIN RESULTS FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED AN INITIAL TROPONIN RESULT OF 0.084 NG/ML. THE PATIENT WAS REDRAWN THREE HOURS LATER AND A TROPONIN RESULT OF 0.015 NG/ML WAS GENERATED. THE FIRST SAMPLE WAS THEN REPEATED WITH A TROPONIN RESULT OF 0.019 NG/ML. THE FIRST SAMPLE WAS ALSO REPEATED ON ANOTHER ARCHITECT I2000 ANALYZER IN THE SAME LABORATORY AND A TROPONIN RESULT OF <0.010 NG/ML WAS GENERATED. THE CUSTOMER USES A CUTOFF VALUE OF 0.028 NG/ML. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222795 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 84111UN13

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| LN 03M74-01, SN (B)(4)