BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 8384677 · Received March 2, 2019

    Report

    Report Number
    1628664-2019-00176
    Event Type
    Malfunction
    Date Received
    March 2, 2019
    Date of Event
    February 13, 2019
    Report Date
    March 2, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE TROUBLESHOOTING THE ISSUE, THE FIELD SERVICE ENGINEER DISCOVERED DAMAGE (CHARRING) OF THE CONTROLLER PWB ON A SMALL AREA AROUND A CAPACITOR ON THE BOARD. THE PART WAS REPLACED TO RESOLVE THE ISSUE. A REVIEW OF THE ANALYZER SERVICE HISTORY FOUND NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE WERE NO SUBSEQUENT REPORTS OF SMOKING/BURN ISSUES SINCE THE PART WAS REPLACED. THE 2019 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 DAMAGE, OBSERVED ON THE CONTROLLER PWB WAS LIMITED TO A SMALL AREA AROUND CAPACITOR C10 ON THE BOARD NEAR FUSE 2; THE DAMAGE DID NOT SPREAD TO OTHER PARTS OF THE INSTRUMENT. A REVIEW OF COMPLAINT AND TRENDING DATA DID NOT IDENTIFY ANY ADVERSE TRENDS FOR TICKETS WITH REPLACEMENTS OF THE CONTROLLER PWB. DURING A 91 MONTH SEARCH FOR SIMILAR COMPLAINTS, NO OTHER COMPLAINTS WERE IDENTIFIED RELATED TO CHARRING ON THE CONTROLLER PWB. A REVIEW OF ARCHITECT I2000SR TRACKING AND TRENDING DATA IN THE PRODUCT MONITORING REVIEW REVEALED NO SYSTEMIC ISSUES OR ADVERSE TRENDS RELATED TO THE ISSUE IDENTIFIED IN THIS COMPLAINT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT I2000SR WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ABBOTT FIELD SERVICE REPRESENTATIVE REPORTED WHILE REPLACING THE IARM CONTROLLER PCW BOARD ON THE ARCHITECT I2000SR ANALYZER, SMOKE WAS OBSERVED. THERE WERE NO INJURIES AND NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177504 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROLLER PWB , PART 7-900505-01