BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 15819611 · Received November 17, 2022

    Report

    Report Number
    3016438761-2022-00539
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    November 4, 2022
    Report Date
    December 20, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    SERVICE FOUND THAT THE CAUSE OF THE SMOKE WAS DUE TO THE ARC BFR SNSR/TUB OVERFLOWING ONTO THE BD, MOTOR DRIVER CAUSE THE BOARD TO SHORT CIRCUIT THEREFORE BURNING/CHARRING. SERVICE REPLACED BOTH THE ARC BFR SNSR/TUB AND BD, MOTOR DRIVER AND DEEMED BOTH THE PARTS THE CAUSE FOR THE SMOKE. THE PART REPLACEMENTS RESOLVED THE ISSUE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. 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/BURNING, OBSERVED WAS LIMITED TO THE BD, MOTOR DRIVER (PART NUMBER 7-900080-01) DUE TO THE ARC BFR SNSR/TUB (LIST NUMBER 08C94-25) OVERFLOWING ONTO THE BOARD; THE ELECTRICAL CHARRING/BURNING DID NOT SPREAD TO OTHER PARTS OF THE MODULE. LABELLING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON ALL REVIEWED DATA, WE CONCLUDE THAT THERE IS NO PRODUCT DEFICIENCY IDENTIFIED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED SMOKE COMING OUT OF THE BACK OF THE ARCHITECT I2000 INSTRUMENT. THE CUSTOMER HAD TO USE A CO2 FIRE EXTINGUISHER AND THE INSTRUMENT WAS POWERED OFF. THE POWER BOARD EXPERIENCED A CONDITION FAULT WHICH LED TO WASH BUFFER LEAKING OUT OF THE TANK. FURTHER INSPECTION SHOWED THAT THE WASH BUFFER TANK HAD OVERFLOWED, FLUID WAS OBSERVED AT THE BASE AND THERE WAS A RESIDUAL SMELL OF BURNING AROUND THE INSTRUMENT. INSPECTION SHOWED THAT THE CARD CAGE WAS WHERE THE INCIDENT HAD OCCURRED, MOTOR DRIVER BOARD NUMBER 3. SCORCHING OF THE COMPONENTS WAS OBSERVED. NO IMPACT OR POTENTIAL IMPACT TO ANALYTICAL / PATIENT RESULT DATA, PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2704837 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown