BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1582386 · Received January 21, 2010

    Report

    Report Number
    1415939-2010-00222
    Event Type
    Malfunction
    Date Received
    January 21, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 14, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    MMI
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL REPORT WAS SUBMITTED UNDER BRAND NAME ARCHITECT STAT TROPONIN-I ASSAY, ABBOTT, (B)(4) MANUFACTURING SITE. IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON BRAND NAME ARCHITECT I2000SR ANALYZER, ABBOTT, (B)(4) MANUFACTURING SITE. EVALUATION RESULTS: ARCHITECT S/N (B)(4) DISCREPANT TROPONIN RESULTS. THE INVESTIGATION BEGAN WITH A REVIEW OF THE CUSTOMER'S INSTRUMENT SYSTEM LOGS. A REVIEW OF THE RETURNED SYSTEM LOGS WAS NOT ABLE TO IDENTIFY THE CAUSE FOR THE CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL (201837-105) AND THE ARCHITECT TROPONIN ASSAY PACKAGE INSERT (840638/R7) CONTAIN INFORMATION ADDRESSING THE CUSTOMER'S PRESENT ISSUE. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION, A SINGLE DEFINITIVE CAUSE WAS NOT DETERMINED FOR THE ABERRANT TROPONIN RESULTS; HOWEVER, THE CUSTOMER USING TWO DIFFERENT CENTRIFUGES COULD HAVE POSSIBLY CONTRIBUTED TO THE OUTCOME. ALSO, SAMPLE COLLECTION AND/OR PREPARATION WERE NOT ABLE TO BE RULED OUT AS POTENTIAL CAUSES OF THE CUSTOMER'S ISSUE. NO PRODUCT MALFUNCTION WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED A FALSE POSITIVE RESULT WITH THE ARCHITECT STAT TROPONIN-I ASSAY. THE FOLLOWING RESULTS WERE PROVIDED FROM TESTING THE PATIENT SAMPLE SEVERAL TIMES: 0.058/0.003/0.002/0.002 NG/ML. THE CUSTOMER USES A CUT-OFF VALUE OF 0.03 NG/ML. THE SAMPLE WAS COLLECTED IN LITHIUM HEPARIN. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB WITH NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    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 I2000SR LN: 3M74-01 (B) (4)| ARCH TROPONIN-I LN:2K41-20