BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR PROCESSING MODULE, REFURBISHED

    MDR report key: 21877218 · Received April 21, 2025

    Report

    Report Number
    3016438761-2025-00240
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    April 14, 2025
    Report Date
    June 17, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ARCHITECT I2000SR, SERIAL NUMBER (B)(6) AND OBSERVED EVIDENCE OF CHARRING/BURNING OF THE AC INPUT MODULE, ARTESYN/ASTEC PS(ROHS) _PART NUMBER 7-92698-03 AND ARC PWR CRD EUR (LIST NUMBER 08L14-01). THE INSTRUMENT SERVICE HISTORY FOR THE ARCHITECT I2000SR, SERIAL NUMBER (B)(6) VERIFIES NO SUBSEQUENT ISSUES HAVE BEEN REPORTED RELATED TO THE MODULE GENERATING ERROR CODES 8000, 0501, 0503 AND 9071 OR CHARRED/BURNED PARTS. A REVIEW OF TRACKING AND TRENDING DATA ASSOCIATED WITH THE AC INPUT MODULE, ARTESYN/ASTEC PS(ROHS) OR THE ARC PWR CRD EUR, DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. ADDITIONALLY, A REVIEW OF TRACKING AND TRENDING DATA FOR THE ARCHITECT I2000SR, SERIAL NUMBER (B)(6) DID NOT IDENTIFY ANY SIMILAR ISSUES. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. THE 2025 UL CERTIFICATION 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 OBSERVED ELECTRICAL SPARK AND SMOKE WAS LIMITED TO THE CHARRED/BURNED PARTS, OBSERVED WAS LIMITED TO THE AC INPUT MODULE, ARTESYN/ASTEC PS(ROHS) AND THE ARC PWR CRD EUR, THE SMELL OF CHARRING/BURNING DID NOT SPREAD TO OTHER PARTS OF THE MODULE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ARCHITECT I2000SR, SERIAL NUMBER (B)(6), AC INPUT MODULE, ARTESYN/ASTEC PS(ROHS) OR THE ARC PWR CRD EUR WAS IDENTIFIED. UPDATED B5: ADDITIONAL INFORMATION PROVIDED. UPDATED H6: MEDICAL DEVICE PROBLEM CODE: ADDED A0704. UPDATED D10 - CONCOMITANT PRODUCT: ADDED ARC PWR CRD EUR, 08L14-01, UNKNOWN.

    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 SEVERAL INSTRUMENT ERROR MESSAGES GENERATED ON THE ARCHITECT I2000SR ANALYZER. THE ERROR MESSAGES GENERATED ON 14APR2025 WERE: 8000 POWER SUPPLY AC FAILED. 0501 POWER ON SELF-TEST (POST) STARTING ON MODULE (1). 0503 SYSTEM CONTROL CENTER (SCC) SHUTDOWN. 9071 RUN-TIME ERROR ENCOUNTERED WHILE RUNNING (6041 DAILY MAINTENANCE) PROCEDURE THE CUSTOMER STATED THERE WAS NO POWER TO ARCHITECT I2000SR ANALYZER AND WOULD NOT START UP. THE FIELD SERVICE ENGINEER (FSE) ARRIVED ONSITE AND FOUND THE AC POWER CONNECTOR (AC INPUT MODULE) WAS CHARRED. THE FSE REPLACED THE AC INPUT MODULE AND A NEW MAIN POWER CABLE. THE INSTRUMENT WAS INITIALIZED WITHOUT GENERATING AN INSTRUMENT ERROR MESSAGE. ON 03JUN2025, ADDITIONAL INFORMATION WAS PROVIDED. THE FIELD SERVICE ENGINEER STATED, SPARKING COULD BE HEARD FROM THE CONNECTOR BUT NOT SEEN. NO WIRES WERE EXPOSED, AND NO ONE WAS INJURED. THE AC INPUT MODULE HAD DISCOLORED CONNECTORS, SO THE CONNECTORS WERE REPLACED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED. THERE WERE NO INJURIES REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED SEVERAL INSTRUMENT ERROR MESSAGES GENERATED ON THE ARCHITECT I2000SR ANALYZER. THE ERROR MESSAGES GENERATED ON 14APR2025 WERE: 8000 POWER SUPPLY AC FAILED, 0501 POWER ON SELF-TEST (POST) STARTING ON MODULE (1). 0503 SYSTEM CONTROL CENTER (SCC) SHUTDOWN. 9071 RUN-TIME ERROR ENCOUNTERED WHILE RUNNING (6041 DAILY MAINTENANCE) PROCEDURE. THE CUSTOMER STATED THERE WAS NO POWER TO ARCHITECT I2000SR ANALYZER AND WOULD NOT START UP. THE FIELD SERVICE ENGINEER (FSE) ARRIVED ONSITE AND FOUND THE AC POWER CONNECTOR (AC INPUT MODULE) WAS CHARRED. THE FSE REPLACED THE AC INPUT MODULE AND A NEW MAIN POWER CABLE. THE INSTRUMENT WAS INITIALIZED WITHOUT GENERATING AN INSTRUMENT ERROR MESSAGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016272 ARCHITECT I2000SR PROCESSING MODULE, REFURBISHED ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740006273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AC INPUT MODULE, ARTESYN/ASTEC PS (ROHS), 7-92698-| AC INPUT MODULE, ARTESYN/ASTEC PS (ROHS), 7-92698-| ARC PWR CRD EUR, 08L14-01, UNKNOWN