BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 2991913 · Received March 6, 2013

    Report

    Report Number
    1415939-2013-00094
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMERS ISSUE INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, ACCURACY TESTING AND REVIEW OF LABELING. REVIEW OF TICKET TRENDING DATA DID NOT IDENTIFY ATYPICAL COMPLAINT ACTIVITY RELATED TO DISCREPANT PATIENT RESULTS. SINCE THE LOT NUMBER IS UNKNOWN A LOT SEARCH WAS NOT PERFORMED. HISTORICAL ACCURACY TESTING WAS REVIEWED FOR A REPRESENTATIVE REAGENT LOT (17330UN12). ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. A DEFICIENCY WAS NOT IDENTIFIED AS PANEL TESTING SHOWS THAT THE ASSAY PERFORMS PER SPECIFICATION. ADDITIONALLY, THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION. THE ISSUE INVOLVES A LIMITED NUMBER OF SAMPLES AND IT IS UNKNOWN IF ANY TROUBLESHOOTING OF THE SAMPLES WAS PERFORMED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO ADDITIONAL ISSUES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED TROPONIN RESULTS WHILE USING THE ARCHITECT I1000SR INSTRUMENT. THE PHYSICIAN PERFORMED A CARDIAC CATHETERIZATION. THE CUSTOMER'S CUTOFF IS 0.028 NG/ML. NO PATIENT DATA OR TEST VALUES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95320 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ARCHITECT I1000SR ANALYZER| LN 01L86-40, SN (B)(4)| LN 01L86-40 SN (B)(4)| ARCHITECT I1000SR ANALYZER