BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 10114851 · Received June 3, 2020

    Report

    Report Number
    3016438761-2020-00084
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 12, 2020
    Report Date
    June 3, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE INSTRUMENT SERVICE HISTORY REVEALED NO ADDITIONAL ISSUES OF A BURNING SMELL OR CHARRING REPORTED ON OR AROUND THE DATE OF THIS COMPLAINT. THE 2020 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 BURN SMELL AND CHARRING WERE LIMITED TO THE POWER CORD, ARCHITECT (ROHS); DAMAGE DID NOT SPREAD TO OTHER PARTS OF THE INSTRUMENT. A REVIEW OF ARCHITECT I2000SR TRACKING AND TRENDING DATA DID NOT IDENTIFY ANY SYSTEMIC ISSUES OR TRENDS RELATED TO THE ISSUE IDENTIFIED IN THIS COMPLAINT. A REVIEW OF MANUFACTURING DOCUMENTATION AND TRENDING DATA ASSOCIATED WITH THE POWER CORD, ARCHITECT (ROHS) DID NOT IDENTIFY ANY ISSUES OR TRENDS. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT I2000SR ANALYZER WAS IDENTIFIED.

    Description of Event or Problem · 1

    WHILE SERVICING AN ARCHITECT I2000SR ANALYZER FOR A POWER ISSUE THE ABBOTT FIELD SERVICE TECHNICIAN FOUND CHARRED WIRING AND EVIDENCE OF DAMAGE TO THE WIRING OF THE ARCHITECT POWER CORD. NO FIRE WAS OBSERVED OR REPORTED. THE CORD WAS REPLACED AND THE ANALYZER POWERED UP SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577504 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT LABORATORIES (IRVING IA/CC) 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1