BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 7648473 · Received June 28, 2018

    Report

    Report Number
    1628664-2018-00260
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 9, 2018
    Report Date
    July 30, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN ABBOTT TECHNICAL SUPPORT SERVICE (TSS) INDIVIDUAL WAS DISPATCHED TO THE ACCOUNT AND FOUND A DAMAGED BOARD [BD, 36V MODULE ARTESYN/ASTEC PS (ROHS) PART 7-92695-02] ON THE ANALYZER. THE TSS NOTED SEVERAL MELTED COMPONENTS ON THIS BOARD. THE SMOKE WAS LIMITED TO THIS PART AND DID NOT SPREAD TO OTHER PARTS OF THE EQUIPMENT. A REPLACEMENT BOARD WAS ORDERED AND WAS INSTALLED BY THE CUSTOMER. THE ANALYZER WAS RETURNED TO NORMAL OPERATION. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A COMPLAINT TEXT REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, DEVICE HISTORY REVIEW FOR THE BOARD, LABELING REVIEW, AND AN INSTRUMENT SERVICE REVIEW. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE. AN 85 MONTH SEARCH RETURNED NO ADDITIONAL COMPLAINTS FOR SMOKE EVENTS INVOLVING THIS BOARD [BD, 36V MODULE ARTESYN/ASTEC PS (ROHS) PART 7-92695-02]. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. PRODUCT LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE, AS IT CONTAINS INSTRUCTIONS REGARDING ELECTRICAL SPECIFICATIONS AND REQUIREMENTS, ELECTRICAL HAZARDS, AND OF ELECTRICAL SAFETY FOR THE ARCHITECT SYSTEMS. ANALYZER SERIAL NUMBER SERVICE HISTORY WAS REVIEWED AND NO CONTRIBUTING FACTORS WERE FOUND. NO SUBSEQUENT REPORTS OF SMOKE/BURN ISSUES WERE IDENTIFIED. THE AFFECTED PART WAS NOT RETURNED. THE ISSUE WAS RESOLVED THROUGH PART REPLACEMENT. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS EVALUATION, NO SYSTEMIC ISSUE WAS IDENTIFIED AND NO PRODUCT DEFICIENCY WAS FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER AND ABBOTT TECHNICAL SUPPORT SERVICE (TSS) OBSERVED SMOKE ON THE 36 VOLT BOARD [BD, 36V MODULE ARTESYN/ASTEC PS (ROHS) PART 7-92695-02] OF THE ARCHITECT I2000SR ANALYZER. PARTS OF THE BOARD WERE MELTED. NO FIRE OR INJURY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488908 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1