BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 PROCESSING MODULE

    MDR report key: 22010441 · Received May 13, 2025

    Report

    Report Number
    3016438761-2025-00285
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 27, 2025
    Report Date
    June 5, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING ON THE ARCHITECT C16000, SERIAL NUMBER (B)(6) AND DISCOVERED THE DAQ BOARD NS, ROHS SHOWED SIGNS OF A SHORT CIRCUIT/CHARRING. THE FSR REPLACED THE DAQ BOARD NS, ROHS, WHICH RESOLVED THE ISSUE. THERE WAS NO FIRE OR SMOKE SEEN NOR FURTHER DAMAGE TO THE INSTRUMENT. THE MODULE WAS DISCONNECTED FROM THE POWER SUPPLY, AND THERE WAS NO INJURY TO PERSONNEL REPORTED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INSTRUMENT SERVICE HISTORY FOR THE ARCHITECT C16000 VERIFIES NO SUBSEQUENT ISSUES HAVE BEEN REPORTED RELATED TO CHARRED/BURNED PARTS. A REVIEW OF TRACKING AND TRENDING OF THE ARCHITECT C16000 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY ASSOCIATED WITH THE COMPLAINT ISSUE. ADDITIONALLY, A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE DAQ BOARD NS, ROHS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE 2025 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/BURNING, OBSERVED WAS LIMITED TO THE DAQ BOARD NS, ROHS COMPLIANT (PART NUMBER 7-93181-07); THE CHARRING/BURNING DID NOT SPREAD TO OTHER PARTS OF THE MODULE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION THE ARCHITECT C16000 SERIAL NUMBER (B)(6) AND DAQ BOARD NS, ROHS IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C16000 AND DAQ BOARD NS, ROHS WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED AN ERROR CODE 5168 CUVETTE TAB NOT DETECTED ON THE ARCHITECT C16000 PROCESSING MODULE. UPON INSPECTION THE DAQ BOARD NS WAS BURNT. UPDATE, ADDITIONAL INFORMATION WAS PROVIDED ON 01MAY2025. THE CUSTOMER WAS CONNECTING THE PRESSURIZED PURIFIED WATER TO THE BACK OF THE INSTRUMENT AND FORGOT TO TURN OFF THE WATER RECEIVER SWITCH. AFTER THE WATER TANK WAS FULL THE WATER SPRAYED TOWARDS THE CEILING AND DRIPPED ONTO THE ANALYZER. THE CUSTOMER SHUT OFF THE ANALYZER AND CLEANED UP THE WATER. THE ANALYZER WOULD NOT TURN BACK ON. UPON INSPECTION, THERE WERE LEADS OF THE ELECTRONIC COMPONENTS ON THE DAQ BOARD THAT HAD SHORTED OUT AND MELTED AND SIGNS OF SHORTING AND BURNING OUT ON THE DAQ BOARD. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THERE WAS NO HARM TO THE USER REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED AN ERROR CODE 5168 CUVETTE TAB NOT DETECTED ON THE ARCHITECT C16000 PROCESSING MODULE. UPON INSPECTION THE DAQ BOARD NS WAS BURNT. UPDATE, ADDITIONAL INFORMATION WAS PROVIDED ON 01MAY2025. THE CUSTOMER WAS CONNECTING THE PRESSURIZED PURIFIED WATER TO THE BACK OF THE INSTRUMENT AND FORGOT TO TURN OFF THE WATER RECEIVER SWITCH. AFTER THE WATER TANK WAS FULL THE WATER SPRAYED TOWARDS THE CEILING AND DRIPPED ONTO THE ANALYZER. THE CUSTOMER SHUT OFF THE ANALYZER AND CLEANED UP THE WATER. THE ANALYZER WOULD NOT TURN BACK ON. UPON INSPECTION, THERE WERE LEADS OF THE ELECTRONIC COMPONENTS ON THE DAQ BOARD THAT HAD SHORTED OUT AND MELTED AND SIGNS OF SHORTING AND BURNING OUT ON THE DAQ BOARD. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THERE WAS NO HARM TO THE USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181654 ARCHITECT C16000 PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DAQ BOARD NS, ROHS COMPLIANT, 7-93181-07, UNKNOWN| DAQ BOARD NS, ROHS COMPLIANT, 7-93181-07, UNKNOWN