BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 2183287 · Received July 28, 2011

    Report

    Report Number
    1415939-2011-00521
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINTS RECEIVED FROM (B)(4) 2011 WERE REVIEWED TO DETERMINE IF OTHERS HAVE EXPERIENCED THE SAME ISSUE. OUR REVIEW IDENTIFIED ATYPICAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION BUT NO ADVERSE TRENDS WERE IDENTIFIED FOR REAGENT LOT 02870UN11. IN ADDITION TESTING WAS PERFORMED TO EVALUATE THE REAGENT LOT AND THE RETURNED PATIENT SAMPLES. A TROPONIN-I PANEL WAS TESTED WITH REAGENT LOT 02870UN11 AND WAS WITHIN SPECIFICATION. THIS DEMONSTRATES THAT OUR ASSAY CAN ACCURATELY DETECT A KNOWN CONCENTRATION OF TROPONIN-I. DILUTION LINEARITY TESTING OF THE PATIENT SAMPLE WAS CONDUCTED. THE RESULTS WERE NOT INDICATIVE OF THE PRESENCE OF AN INTERFERING SUBSTANCE IN THE PATIENT SAMPLE. DUE TO LIMITED SAMPLE VOLUME, WE WERE UNABLE TO COMPLETE THE HETEROPHILIC BLOCKING TUBE TEST, WHICH COULD HAVE IDENTIFIED IF HETEROPHILIC ANTIBODIES WERE PRESENT. THE CUSTOMER WAS REFERRED TO THE ARCHITECT STAT TROPONIN-I REAGENT PACKAGE INSERT "LIMITATIONS OF THE PROCEDURE" SECTION FOR FURTHER INFORMATION. BASED ON THE RESULTS OF THIS INVESTIGATION, THE ARCHITECT STAT TROPONIN-I REAGENTS ARE PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ANGIOGRAPHY WAS PERFORMED DUE TO ELEVATED ARCHITECT TROPONIN-I RESULTS. NO INJURY WAS REPORTED. (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 STATED AN OUTPATIENT WAS ADMITTED TO THE HOSPITAL FOR TWO DAYS BECAUSE OF ELEVATED ARCHITECT TROPONIN-I RESULTS. THE CUSTOMER STATED, PER PHYSICIANS, THERE WERE NO OTHER INDICATIONS OF AN MI EXCEPT THE ELEVATED ARCHITECT TROPONIN-I RESULTS. ARCHITECT RESULTS OF 4.71, 4.77, 3.82, 3.93, 4.16, 4.30, 4.13 AND 4.47 NG/ML WERE OBTAINED OVER A THREE DAY PERIOD (NORMAL RANGE < 0.02 NG/ML). ON THE FIRST DAY, SAMPLES WERE ALSO TESTED ON THE ISTAT METHOD WITH RESULTS OF 0.00, 0.03, 0.00 AND 0.00. AN ANGIOGRAPHY WAS PERFORMED ON THE PATIENT. THE PATIENT WAS SUBSEQUENTLY DISCHARGED. THERE WAS NO REPORT OF INJURY DUE TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 02870UN11

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O (B)(4)| ARCHITECT I2000SR ANALYZER LIST # 3M74-01| (B)(4)| ARCHITECT I2000SR ANALYZER LIST # 3M74-01