BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 6995203 · Received November 1, 2017

    Report

    Report Number
    1628664-2017-00413
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    October 11, 2017
    Report Date
    November 15, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER WAS DISPATCHED TO THE ACCOUNT AND WHILE INVESTIGATING, FOUND A LEAK FROM THE R2 REAGENT WASH STATION THAT CONTACTED THE QUAD MODULE BOARD [PART 7-92696-02]. THE LEAK FROM THE WASH STATION CAUSED THE BOARD TO SHORT OUT. THE DAMAGE WAS LIMITED TO THIS BOARD ONLY AND DID NOT SPREAD TO OTHER PARTS OF THE INSTRUMENT. THE FSE REPLACED THE BOARD, WHICH RETURNED THE ANALYZER TO NORMAL OPERATION. THE FSE ALSO OBTAINED CLARIFICATION FROM THE CUSTOMER THAT NO FLAME WAS OBSERVED WHEN THE INCIDENT OCCURRED, ONLY A BURNING SMELL WAS DETECTED. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT, INSTRUMENT SERVICE HISTORY REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, A LABELING REVIEW, AND A REVIEW OF TRACKING DATA FOR THE PARTS INVOLVED. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. ANALYZER SERIAL NUMBER (B)(4) SERVICE HISTORY WAS REVIEWED AND NO CONTRIBUTING FACTORS WERE FOUND. NO SUBSEQUENT REPORTS OF SMOKE/BURN ISSUES WERE IDENTIFIED AFTER THE REPAIR. PRODUCT LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE, AS IT CONTAINS INFORMATION REGARDING ELECTRICAL HAZARDS, ELECTRICAL SPECIFICATIONS AND REQUIREMENTS, AND ELECTRICAL SAFETY FOR THE ARCHITECT SYSTEMS AS WELL AS INSTRUCTIONS FOR PERFORMING AN EMERGENCY SHUTDOWN OF THE ARCHITECT I2000 ANALYZER. HISTORICAL COMPLAINT DATA WAS REVIEWED. NO ADVERSE TREND OR SYSTEMIC ISSUE WAS IDENTIFIED FOR THE ISSUE IDENTIFIED IN THE COMPLAINT. NO ADVERSE TRENDS FOR REPLACEMENTS OF THESE PARTS WERE IDENTIFIED IN THE LAST 12 MONTHS. A 76 MONTH REVIEW OF SPARKING/BURNING ISSUES DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS FOR THE COMBINATION OF THE QUAD MODULE BOARD [PART 7-92696-02] AND WASH STATION, REAGENT, BYPASSED GUTTER [PART 7-78133-04]. HOWEVER, ONE COMPLAINT WAS IDENTIFIED THAT INCLUDED A QUAD MODULE BOARD THAT BECAME DAMAGED/BURNED FROM THE TRIGGER/PRE-TRIGGER WASTE TUBING LEAKAGE. NO DEFICIENCY WAS IDENTIFIED IN THAT REPORTED EVENT, REFER TO MANUFACTURER REPORT NUMBER 1628664-2016-00316. THE QUAD MODULE BOARD IS UTILIZED ON ARCHITECT I2000 AND I2000SR ANALYZERS, WITH A COMBINED PART CENSUS OF 12,166 AS OF SEPTEMBER 2017. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS EVALUATION, NO SYSTEMIC ISSUE WAS IDENTIFIED AND NO PRODUCT DEFICIENCY WAS FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT I2000 ANALYZER WENT OFFLINE AND THE CUSTOMER SWITCHED THE ANALYZER ON AND OFF. WHEN THE CUSTOMER RETURNED TO THE ANALYZER, THEY HEARD A NOISE AND OBSERVED A FLAME. WHILE REPAIRS WERE BEING MADE, THE ABBOTT FIELD SERVICE REPRESENTATIVE FOUND A LEAK IN THE WASH STATION R2 ARM NEEDLE AND FOUND THE BD, QUAD MODULE [PART 7-92696-02] DAMAGED BY THE LEAK. PARTS BD, QUAD MODULE [PART 7-92696-02] AND WASH STATION, REAGENT, BYPASSED GUTTER [PART 7-78133-04] WERE REPLACED. NO INJURY OR EXPOSURE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772444 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1