BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1579881 · Received January 19, 2010

    Report

    Report Number
    1628664-2010-00011
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    January 4, 2010
    Report Date
    January 7, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    MMI
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARCH STAT TROPONIN-I LN:2K41 LOT: 34609UN09 EXPIRES: 31 AUGUST 2010. TO INVESTIGATE THE CURRENT CUSTOMER ISSUE, A REVIEW WAS PERFORMED OF THE COMPLAINT TEXT, INSTRUMENT HISTORY, AND THE ARCHITECT SYSTEM LABELING. ERRONEOUS RESULTS GENERATED FOR ONE OF THE SAMPLES IN QUESTION MAY HAVE BEEN CAUSED BY A HIGH FIBRIN CONTENT OBSERVED IN THE SAMPLE. THE CUSTOMER WAS NOT FOLLOWING THE ARCHITECT OPERATIONS MANUAL INSTRUCTIONS ON USING 0.5% HYPOCHLORITE SOLUTION FOR THE DAILY MAINTENANCE PROCEDURE. THE CUSTOMER WAS USING A 1% SOLUTION INSTEAD. A REVIEW OF THE SERVICE HISTORY FOR THE ARCHITECT I2000SR ANALYZER, (B)(4), ALONG WITH THE COMPLAINT DATABASES IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL (201837-105) AND THE STAT TROPONIN-I (TNI II) REAGENT PACKAGE INSERT (840638/R7) BOTH CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S ISSUE. BASED ON THE AVAILABLE INFORMATION FOR THIS CURRENT INVESTIGATION, A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ARCH STAT TROPONIN-I: LN:2K41, LOT: 34609UN09, EXPIRES: 31 AUGUST 2010. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT GENERATED THE FOLLOWING ARCHITECT STAT TROPONIN-I ASSAY RESULTS: (B)(6) 2010: 13:40, 0.05 NMOL/L; (B)(6) 2010: 18:00, 0.06 NMOL/L; (B)(6) 2010: 00.05, 0.01 NMOL/L (ISTAT METHODOLOGY); (B)(6) 2010: 0.13 NMOL/L; ISTAT RESULTS:0.01 / 0.00 NMOL/L. THE (B)(4) 2010 SAMPLE WAS RECENTRIFUGED AND RETESTED AND GENERATED AN ARCHITECT STAT TROPONIN-I ASSAY RESULT OF 0.05 NMOL/L. THE CUSTOMER USES A CUT-OFF VALUE OF 0.03 NG/ML. CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER MMI ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH STAT TROPONIN-I: LN:2K41-38| ARCH STAT TROPONIN-I: LN:2K41-38