BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 3172254 · Received June 17, 2013

    Report

    Report Number
    1415939-2013-00265
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 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). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAULATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE 4. CATALOG # CORRECTED FROM 02K41-25 TO 02K41-37. THE CUSTOMER OBSERVED A DISCREPANT PATIENT RESULT, WHILE USING ARCHITECT STAT TROPONIN-I, LIST 2K41-37 LOT 84111UN13 AND LIST 2K41-01 LOT 172477. REVIEW OF TICKET TRENDING AND LOT SEARCH DATA FOR LOT 84111UN13 DID NOT IDENTIFY UNUSUAL COMPLAINT ACTIVITY RELATED TO DISCREPANT PATIENT RESULTS. HOWEVER, INCREASED COMPLAINT ACTIVITY WAS IDENTIFIED FOR TROPONIN CALIBRATOR LOT 172477. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 84111UN13 AND CALIBRATOR LOT 172477. ALL ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. ADDITIONALLY, THE 3 RETURNED PATIENT SAMPLES WERE TESTED VIA THE ANALYTICAL SPECIFICITY TESTING PLAN WITH THE LOT 84111UN13 AND 172477. ONE VIAL WAS TREATED WITH A HETEROPHILIC BLOCKING TUBE (HBT), AND MANUAL DILUTIONS WERE PREPARED USING THE REMAINING TWO VIALS. THE HBT TESTING WAS INCONCLUSIVE SINCE THE RESULTS WERE INCONSISTENT. DUE TO THE INCONCLUSIVE HBT RESULTS IT CANNOT BE DETERMINE IF THE INTERFERENT WAS DUE TO A HETEROPHILIC ANTIBODY OR IF IT IS INDICATIVE OF A COMPROMISED SAMPLE. A DEFICIENCY WAS NOT IDENTIFIED AS PANEL TESTING SHOWS THAT THE LOTS PERFORMED PER SPECIFICATION. THE CUSTOMER WAS REFERRED TO THE ARCHITECT STAT TROPONIN-I REAGENT PACKAGE INSERT, "LIMITATIONS OF THE PROCEDURE" SECTION FOR ADDITIONAL INFORMATION REGARDING THE ISSUE. NO MALFUNCTION HAS OCCURRED SINCE THE DISCREPANT RESULTS WERE FOR A DISCREET PATIENT AND THERE IS NO INDICATION IN THE ASSAY PACKAGE INSERT IF THE ARCHITECT STAT TROPONIN-I ASSAY CORRELATES WITH THE ISTAT ASSAY. 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 COMPARED TO THE ISTAT TROPONIN. THE ER ISTAT RESULT WAS 0.35NG/ML AND THEN 30 MINUTES LATER THE ARCHITECT RESULT WAS 3.4 NG/ML (CUSTOMER CUTOFF FOR BOTH ISTAT AND ARCHITECT TROPONIN IS 0.04NG/ML). BOTH OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN. THIS SAMPLE WAS LITHIUM HEPARIN WHOLE BLOOD, DRAWN (B)(6) 2013 AT 8 AM. THIS SAME SAMPLE WAS CENTRIFUGED AND THE PLASMA WAS RUN ON THE ISTAT ON THE HOSPITAL FLOOR AND GENERATED A RESULT OF 0.31 NG/ML. A SECOND SAMPLE WAS THEN DRAWN ON (B)(6) 2013 AT 10 AM AND GAVE SIMILAR RESULTS AS THE FIRST BLOOD DRAW. THERE WAS NO REPORTED TREATMENT GIVEN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272992 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 84111UN13

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR ARCHITECT I2000SR ANALYZER, LIST # 03M74-02| SERIAL # (B)(4)