BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1894293 · Received November 9, 2010

    Report

    Report Number
    1628664-2010-00406
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER WAS INSTRUCTED TO REPLACE THE STAT PROBE. NO RECURRENCE OF ERRATIC RESULTS HAS BEEN IDENTIFIED. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND RELATED TO DISCREPANT TROPONIN-I RESULTS. PACKAGE INSERT AND OPERATIONS MANUAL LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE EVALUATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSE POSITIVE TROPONIN-I RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT I2000SR GENERATED AN INITIAL TROPONIN-I RESULT OF 54.2 NG/L AND A REPEAT TROPONIN-I RESULT OF 25.7 NG/L. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH TROPONIN-I REAGENT LN 2K41-28 LOT 39419UN10| ARCH TROPONIN-I REAGENT LN 2K41-28 LOT 39419UN10