BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 2220893 · Received August 23, 2011

    Report

    Report Number
    1415939-2011-00537
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OUR REVIEW OF THIS DATA DID NOT IDENTIFY ANY PROBLEMATIC COMPLAINT ACTIVITY THAT WOULD INDICATE THIS PRODUCT IS PERFORMING CONTRARY TO ITS CLAIMS. TO EVALUATE THE ASSAY'S PERFORMANCE, WE TESTED AN INTERNAL TROPONIN-I PANEL WITH REAGENT LOT, 13140UN11. THE PANEL WAS WITHIN SPECIFICATION, WHICH DEMONSTRATES THAT OUR ASSAY CAN ACCURATELY DETECT A KNOWN CONCENTRATION OF TROPONIN-I. A DILUTION LINEARITY TEST WAS PERFORMED AND SHOWED THE PRESENCE OF INTERFERING SUBSTANCES, HOWEVER THE HETEROPHILIC BLOCKING TUBE TESTING RULED OUT THE PRESENCE OF HETEROPHILIC ANTIBODIES. THE SOURCE OF THE DISCREPANCY IS THE PATIENT SPECIMEN AND NOT THE ABBOTT PRODUCT. BASED ON THE RESULTS OF THIS INVESTIGATION, ARCHITECT STAT TROPONIN-I REAGENT LOT 13140UN11 IS PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED A PATIENT GENERATED FALSE ELEVATED TROPONIN-I RESULTS ON THE ARCHITECT I1000SR ANALYZER. THE PATIENT HAS HAD CONTINUED COMPLAINTS OF FATIGUE AND SHORTNESS OF BREATH. THE PATIENT PRESENTED TO THE ER WITH THESE COMPLAINTS ON (B)(6), 2011 AND ELEVATED ARCHITECT TROPONIN-I RESULTS WERE GENERATED. EACH TIME, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER CARDIAC EVALUATION AND RESULTS WERE NEGATIVE, INCLUDING TROPONIN (METHOD NOT STATED). ON (B)(6), 2011, THE PATIENT WENT TO HER PRIMARY CARE PHYSICIAN FOR EVALUATION AND AN ELEVATED TROPONIN-I RESULT WAS GENERATED ON THE ARCHITECT. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND MONITORING. FIVE BLOOD SAMPLES WERE OBTAINED BETWEEN (B)(6), 2011, AND YIELDED ELEVATED ARCHITECT TROPONIN-I RESULTS (4.93, 5.65, 4.80, 4.54 AND 4.19 NG/ML) BUT THE SAMPLES WERE NEGATIVE (0.00) ON THE ISTAT AND RPH RXL TROPONIN METHODS. THE CUSTOMER BELIEVES THE FALSELY ELEVATED ARCHITECT TROPONIN-I RESULTS ARE DUE TO AN INTERFERING SUBSTANCE IN THE PLASMA AND SERUM OF THE PATIENT. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 13140UN11

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR ARCHITECT I1000SR ANALYZER LIST # 1L86-40| ARCHITECT I1000SR ANALYZER LIST # 1L86-40| SERIAL # (B)(4)| SERIAL # (B)(4)