BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 14844791 · Received June 28, 2022

    Report

    Report Number
    3016438761-2022-00289
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 22, 2022
    Report Date
    August 25, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE LAMP WAS REPLACED RESOLVING THE ISSUE. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. THE ARCHITECT SYSTEM OPERATIONS MANUAL CONTAINED ADEQUATE INFORMATION FOR THE TROUBLESHOOTING, REMOVAL, AND REPLACEMENT OF THE PART. A REVIEW OF THE ACHITECT C800253 SERVICE HISTORY REVEALED NO ADDITIONAL ISSUES OF CHARRING OF PARTS. THE 2022 UL CERTIFICATION MEMO INDICATES THAT ABBOTT DIAGNOSTIC EQUIPMENT AND ACCESSORIES ARE CERTIFIED TO THE APPROPRIATE SAFETY STANDARDS, AND ADEQUATE PROTECTION IS PROVIDED FOR THE OPERATOR AGAINST SPREAD OF FIRE FROM THE EQUIPMENT. THE CHARRING, OBSERVED WAS LIMITED TO THE CABLE OF THE LAMP. THE CHARRING DID NOT SPREAD TO OTHER PARTS OF THE MODULE. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT AN OPTICS ERROR WAS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE. WHILE REPLACING THE LAMP TO RESOLVE THE ERROR, THE CUSTOMER NOTED A MELTED LAMP CABLE. THERE WAS NO OBSERVED FIRE OR SMOKE, AND NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939372 ARCHITECT C8000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown