BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 6716872 · Received July 17, 2017

    Report

    Report Number
    1628664-2017-00285
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    June 20, 2017
    Report Date
    July 17, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION BY THE FIELD SERVICE ENGINEER (FSE) REVEALED FLUID FROM THE WZ 2 BUFFER HEATER LEAKED ONTO THE WZ PROBE MOTOR AND THE ASSOCIATED LEFT BACK CABLE HARNESS. THE LEAK CAUSED A "SMALL ELECTRIC ARC" THAT RESULTED IN A BURNT CONTACT ON THE MOTOR'S ELECTRICAL CONNECTOR. THE FSE REPLACED THE WZ MOTOR (PART NUMBER 7-78851-01); THE LEFT BACK CABLE HARNESS (PART NUMBER 7-93915-01); AND THE WZ BUFFER HEATER (PART NUMBER 7-78306-02). THERE HAVE BEEN NO FURTHER OCCURRENCES AFTER THE PARTS WERE REPLACED. A REVIEW OF THE ARCHITECT ISR01440 SERVICE HISTORY DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE CURRENT COMPLAINT. A REVIEW OF THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES THE USER ADEQUATE INFORMATION REGARDING ELECTRICAL HAZARDS AND PERFORMING AN EMERGENCY SHUTDOWN OF THE I2000SR. THE 2017 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. EVALUATION OF COMPLAINT DATA FOR THE WZ MOTOR (PART NUMBER 7-78851-01); THE LEFT BACK CABLE HARNESS (PART NUMBER 7-93915-01); OR THE WZ BUFFER HEATER (PART NUMBER 7-78306-02) DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY AND NO TRENDS FOR THE REPORTED ISSUE. A REVIEW OF COMPLAINTS FOR THE ARCHITECT I2000SR FOUND NO TRENDS WITH REGARD TO THIS ISSUE. A MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. HOWEVER, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A SPARK AND SMOKE COMING FROM THE ARCHITECT ANALYZER ON (B)(6) 2017 FROM THE BACK RIGHT SIDE. THERE WAS NO VISIBLE FIRE. THE CUSTOMER TURNED THE POWER OFF. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497456 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1