BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 5806989 · Received July 19, 2016

    Report

    Report Number
    1628664-2016-00196
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 29, 2016
    Report Date
    October 5, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND INSPECTED THE ARCHITECT C4000 ANALYZER. THE FSE IDENTIFIED THE SCC-F+ POWER SUPPLY (LN 7-206072-01) AS THE SOURCE OF THE SMOKE. THE POWER SUPPLY WAS REPLACED TO ADDRESS THE ISSUE. THE SCC POWERED UP AS EXPECTED AND NO ADDITIONAL ISSUES ASSOCIATED WITH THE SCC AFTER THE POWER SUPPLY WAS REPLACED WERE OBSERVED. ADDITIONALLY, THE FSE STATED THAT WAS NO EVIDENCE OF DAMAGE OUTSIDE THE POWER SUPPLY. THE POWER SUPPLY SCC F+ (LN 7-206072-01) WAS RETURNED FOR INSPECTION. THE PART WAS DETERMINED TO BE NONFUNCTIONING. THE CONDITION OF THE PART WAS DESCRIBED AS HAVING A BURNED COMPONENT ON THE CIRCUIT BOARD INSIDE THE POWER SUPPLY. TESTING WAS NOT PERFORMED AS A VISUAL INSPECTION CONFIRMED THE BURNED COMPONENT INSIDE THE POWER SUPPLY. THIS REVIEW REVEALED A CIRCUIT BOARD WITH A SMALL DISCOLORED (DARK BROWN/BLACK) AREA ADJACENT TO IT. THE AREA APPEARS TO INDICATE CHARRING BUT APPEARS TO BE CONTAINED. THE PERFORMANCE OF THE COMPLAINT PRODUCT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE. NO PRODUCT DEFICIENCY WAS IDENTIFIED. HOWEVER, A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED OVER THE PAST 63 MONTH PERIOD AND FOUND ADDITIONAL COMPLAINTS ASSOCIATED WITH SMOKE/BURNING OF THE SCC-F+ POWER SUPPLY. AN INVESTIGATION IS ON-GOING TO FURTHER UNDERSTAND THE MECHANISM AND OCCURRENCE OF THIS ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT C4000 SYSTEM AND SUPPORT MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT DEFICIENCY EXISTS. THE ISSUE WAS RESOLVED BY THE FSE THROUGH STANDARD TROUBLESHOOTING PROCEDURES.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS ISSUES WITH THE SYSTEM CONTROL CENTER (SCC) OF THE ARCHITECT C4000 ANALYZER (NO SPECIFICS DOCUMENTED). THE CUSTOMER REBOOTED THE SCC AND REPORTS HEARING A "POP" ACCOMPANIED BY THE ODOR OF SMOKE AND FOLLOWED BY VISIBLE SMOKE COMING FROM THE SCC. NO INJURIES WERE REPORTED. THERE WAS NO DAMAGE TO ANY OF THE SURROUNDING LAB ENVIRONMENT. A SERVICE CALL WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458741 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1