BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 9553494 · Received January 6, 2020

    Report

    Report Number
    1628664-2020-00005
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 13, 2019
    Report Date
    January 22, 2020
    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 · 0

    DURING THE SITE VISIT, THE FIELD SERVICE REPRESENTATIVE (FSR) OBSERVED SMOKE COMING FROM THE I2000SR PROCESSING MODULE. THE FSR DISCOVERED THAT THE CUSTOMER HAD INCORRECTLY INSTALLED THE ARC PROBE, CAUSING THE PROBE TO SPRAY LIQUID EVERYWHERE, INCLUDING THE BACKSIDE OF THE R2 SYRINGE BOARD. THIS IN TURN CAUSED THE MOTOR, SHUTTER OF WZ AND CABLE HARNESS, LEFT BACK ABOVE #3 (ROHS) COMPONENTS TO HAVE HEAT DAMAGE. THE FSR REPLACED THE ARC, PROBE (LIST NUMBER 08C94-47), MOTOR, SHUTTER OF WZ, PART NUMBER 7-78851-01, AND THE CABLE HARNESS, LEFT BACK ABOVE #3 (ROHS), PART NUMBER 7-93915-01 WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT I2000SR, SERIAL NUMBER (B)(4) INSTRUMENT SERVICE HISTORY REVEALED NO ADDITIONAL ISSUES OF SMOKE REPORTED ON OR AROUND THE DATE OF THIS COMPLAINT. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION REGARDING ELECTRICAL HAZARDS, EMERGENCY SHUTDOWN PROCEDURES, AND ELECTRICAL SAFETY PARAMETERS FOR THE I2000SR PROCESSING MODULE. THE ARCHITECT SERVICE MANUAL CONTAINS ADEQUATE INFORMATION FOR THE TROUBLESHOOTING, REMOVAL, AND REPLACEMENT OF THE IMPACTED PARTS. 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. A 12-MONTH REVIEW OF TICKETS FOR THE ARC, PROBE, THE MOTOR, SHUTTER OF WZ, AND THE CABLE HARNESS, LEFT BACK ABOVE #3 DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. A REVIEW OF THE ARCHITECT I2000SR SYSTEMS FOUND NO TRENDS WITH REGARDS TO THE CURRENT ISSUE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT ANALYZER, SERIAL NUMBER (B)(4), OR THE ARC, PROBE (LIST NUMBER 08C94-47), MOTOR, SHUTTER OF WZ, PART NUMBER 7-78851-01, OR THE CABLE HARNESS, LEFT BACK ABOVE #3 (ROHS), PART NUMBER 7-93915-01.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED ERROR CODE 7003 [TEMPERATURE ALARM FROM CHANNEL (8), READING (47862).] AND EC7007 [TEMPERATURE FAILED CHANNEL (8), CANNOT REACH READY STATUS (PROCESS PATH ZONE 3).] ON THE ARCHITECT ANALYZER. THE CUSTOMER CYCLED POWER WHICH RESOLVED THE ISSUE FOR A SHORT TIME, BUT THE ERRORS RETURNED. ON 13DEC2019 WHEN THE ABBOTT FIELD SERVICE REPRESENTATIVE WAS ON SITE TO ADDRESS THE ISSUE, HE SAW SMOKE COMING FROM THE ANALYZER. THE FSR FOUND BURN MARKS ON PARTS AND MELTED COMPONENTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17896 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1