BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 4241341 · Received November 10, 2014

    Report

    Report Number
    1628664-2014-00232
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER POWERING THE ARCHITECT I1000SR (SERIAL NUMBER (B)(4)) TO THE ON POSITION, THE CUSTOMER HEARD A BURSTING SOUND AND OBSERVED SMOKE COMING FROM THE INSTRUMENT. NO INJURIES OCCURRED. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE SOURCE OF THE SMOKE WAS DUE TO A BOARD INSIDE THE DC POWER SUPPLY ASSEMBLY. THE INSTRUMENT WAS INSPECTED, AND NO EVIDENCE OF LEAKING WAS FOUND. NO ISSUE WAS OBSERVED WITH THE LABORATORY'S ELECTRICAL REQUIREMENTS. THE ISSUE WAS RESOLVED BY REPLACING THE DC POWER SUPPLY ASSEMBLY. A PICTURE OF THE BOARD HOUSED INSIDE THE DC POWER SUPPLY ASSEMBLY WAS PROVIDED. THE PICTURE PROVIDES EVIDENCE OF A BURNT RESISTER ON THE BOARD WITHIN THE DC POWER SUPPLY ASSEMBLY. A REVIEW OF SERVICE TICKETS RECEIVED FOR THE I1SR50128 WAS PERFORMED. THIS REVIEW IDENTIFIED NO CONTRIBUTING FACTOR ON OR AROUND THE DATE OF THE EVENT. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS RELATED TO THE DC POWER SUPPLY ASSEMBLY WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. INFORMATION REGARDING ELECTRICAL HAZARDS AND INSTRUCTIONS FOR PERFORMING AN EMERGENCY SHUTDOWN OF THE I1000SR IS PROVIDED. THE SAFETY HAZARDS MEMO CONTAINS ADEQUATE INFORMATION NOTING 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 INVESTIGATION DID NOT IDENTIFY A DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT WHEN THEY TURNED ON THE ARCHITECT I1000SR ANALYZER THEY HEARD A BURSTING SOUND AND SAW SMOKE COMING FROM THE ANALYZER. SERVICE WAS DISPATCHED AND FOUND THE INSTRUMENT POWER SUPPLY WAS DAMAGED. UPON OPENING THE POWER SUPPLY , TRACES OF COMPONENT BURSTING AND BLACKENING WERE SEEN ON ONE OF THE BOARDS. THE POWER SUPPLY ASSEMBLY WAS REPLACED. NO INJURY OR DAMAGE OUTSIDE OF THE SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723704 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1