BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 17344659 · Received July 18, 2023

    Report

    Report Number
    3016438761-2023-00384
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    July 18, 2023
    Report Date
    August 11, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE SUBSEQUENT SITE VISIT BY THE FIELD SERVICE ENGINEER (FSE) THE ANALYZER WAS INSPECTED, SERVICE FOUND MULTIPLE CORRODED CONNECTORS AND THAT THE BACKPLANE CONNECTOR J275 ON THE CARD CAGE, I2000SR (ROHS) WAS BURNED/CHARRED, THE CHARRING/BURN DID NOT SPREAD TO OTHER PARTS OF THE ANALYZER. ADDITIONAL TROUBLESHOOTING FROM SERVICE RESULTING IN THE NOT ONLY THE CARD CAGE, I2000SR (ROHS)_PART NUMBER 7-93727-02 BEING REPLACED THE DUAL MOTOR SENSOR BOARD (ROHS)_PART NUMBER 7-900625-01 AND INDEXER BOARD, TESTED (PART NUMBER 7-204347-04) BEING REPLACED AS WELL. ALL THREE PARTS WERE DEEMED THE LIKELY CAUSES FOR THE ISSUE. THE MODULE FUNCTION WAS VERIFIED WITH A QC RUN. A REVIEW OF THE ANALYZER SERVICE HISTORY AND LOGS IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER OCCURRENCES SINCE THE SITE VISIT BY THE FSE. THE ARCHITECT OPERATIONS MANUAL CONTAINS ADEQUATE INFORMATION FOR TROUBLESHOOTING THE OBSERVED ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE CLINICAL CHEMISTRY PLATFORMS TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS WITH REGARDS TO THE CURRENT ISSUE. THE 2023 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. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE ABBOTT TECHNICAL SUPPORT SPECIALIST REPORTED VISIBLE SMOKE FROM THE BURNT CARD CAGE BACKPLANE CONNECTOR J275. ABBOTT TSS REMOVED ALL CABLES FROM THE CARD CAGE BACKPLOANE AND FOUND MULTIPLE CORRODED CONNECTORS. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Description of Event or Problem · 0

    THE ABBOTT TECHNICAL SUPPORT SPECIALIST REPORTED VISIBLE SMOKE FROM THE BURNT CARD CAGE BACKPLANE CONNECTOR J275. ABBOTT TSS REMOVED ALL CABLES FROM THE CARD CAGE BACKPLOANE AND FOUND MULTIPLE CORRODED CONNECTORS. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766565 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CARD CAGE, I2000SR (ROHS), 7-93727-02, UNKNOWN| CARD CAGE, I2000SR (ROHS), 7-93727-02, UNKNOWN