BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 5914569 · Received August 30, 2016

    Report

    Report Number
    1628664-2016-00221
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Date of Event
    August 5, 2016
    Report Date
    September 13, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 REPRESENTATIVE (FSR) WAS DISPATCHED TO THE ACCOUNT AND FOUND THE ARCHITECT C8000 ANALYZER CENTRAL PROCESSING UNIT (CPU) WAS NOT COMMUNICATING WITH THE SYSTEM CONTROL CENTER (SCC). THE FSR REPLACED THE DATA ACQUISITION BOARD (DAQ) AND THE INSTRUMENT BOOTED UP SUCCESSFULLY. INSPECTION OF THE DAQ BOARD FOUND A DAMAGED CHIP. THE DISCOLORATION WAS ISOLATED TO A SINGLE CHIP AND THE SOLDER JOINTS FOR THIS CHIP ON THE BOARD. THE SMOKE FROM THE ANALYZER WAS LIMITED TO THIS PART AND DID NOT SPREAD TO OTHER PARTS OF THE EQUIPMENT. THE ANALYZER WAS RETURNED TO NORMAL OPERATION. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING, AND A REVIEW OF INSTRUMENT SERVICE. RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION, IN ADDITION TO PHOTOGRAPHS OF THE DAMAGED DAQ BOARD. ARCHITECT C8000 ANALYZER SERIAL NUMBER (B)(4) SERVICE HISTORY WAS REVIEWED AND NO CONTRIBUTING FACTORS WERE FOUND. NO SUBSEQUENT REPORTS OF SMOKE/BURN ISSUES WERE IDENTIFIED. HISTORICAL COMPLAINT DATA WAS REVIEWED FOR A 62 MONTH PERIOD AND NO ADVERSE TREND WAS IDENTIFIED. NO SIMILAR COMPLAINTS ASSOCIATED WITH THE DAQ BOARD WERE FOUND. PRODUCT LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED THROUGH NORMAL TROUBLESHOOTING PROCEDURES. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION FOR THE ARCHITECT C8000 ANALYZER, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A BURNING ODOR FROM THE BACK LEFT SIDE OF THE ARCHITECT C8000 ANALYZER IN THE CARD CAGE AREA. THE CUSTOMER WAS RUNNING QC AT THE TIME OF THE ISSUE, AND NO PATIENT SAMPLES WERE IMPACTED. THE CENTRAL PROCESSING UNIT (CPU) FAILED TO BOOT UP AND DID NOT CONNECT TO THE SYSTEM CONTROL CENTER (SCC). ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE DATA ACQUISITION BOARD (DAQ). THE FSR OBSERVED EVIDENCE OF A DAMAGED CHIP ON THE DAQ THAT HAD OVERHEATED. NO FIRE OR SMOKE WAS REPORTED AND NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566741 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1