BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1428964 · Received August 5, 2009

    Report

    Report Number
    1628664-2009-00293
    Event Type
    Malfunction
    Date Received
    August 5, 2009
    Date of Event
    July 14, 2009
    Report Date
    July 15, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) VISITED THE CUSTOMER SITE AND REPLACED THE DAMAGED QUAD MODULE BOARD (PART NO. 7-92696-01) TO RESOLVE THE ISSUE. THE FSR VERIFIED THE I2000SR ANALYZER'S PERFORMANCE BY POWERING THE SYSTEM ON, PERFORMING DAILY MAINTENANCE, AND RUNNING SUCCESSFUL CONTROL RUNS. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THE ARCHITECT SYSTEM OPERATIONS MANUAL (B)(4) WAS REVIEWED AND WAS FOUND TO CONTAIN ADEQUATE INFORMATION (SECTION 8) ON POTENTIALLY DANGEROUS CONDITIONS ON THE ARCHITECT SYSTEMS. A SIX MONTH SEARCH FOR SIMILAR COMPLAINTS WAS PERFORMED WITH NO ADDITIONAL COMPLAINTS WERE FOUND DUE TO ARCHITECT I2000SR QUAD MODULE BOARDS BURNING OUT AND EMITTING SMOKE. NO ADDITIONAL CUSTOMER COMPLAINTS FOR ARCHITECT I2000SR SERIAL NUMBER (B)(4) WERE FOUND TO HAVE BEEN INITIATED FOR BURNING OR SMOKING ISSUES SINCE THE FSR REPLACED THE QUAD MODULE BOARD. ABBOTT DIAGNOSTIC EQUIPMENT AND ACCESSORIES ARE CERTIFIED TO THE APPROPRIATE SAFETY STANDARDS, AND ADEQUATE PROTECTION IS PROVIDED FOR THE OPERATOR AGAINST ELECTRICAL SHOCK OR BURN, EXCESSIVE TEMPERATURE, AND SPREAD OF FIRE FROM THE EQUIPMENT. A MALFUNCTION OF THE ARCHITECT I2000SR ANALYZER WAS IDENTIFIED. THE QUAD MODULE BOARD RESISTER BURNED OUT AND SHATTERED. THE CAUSE OF THE QUAD MODULE BOARD RESISTER MALFUNCTION IS NOT KNOWN. THE CUSTOMER INSTALLED A RESISTOR PURCHASED FROM A LOCAL ELECTRONICS STORE IN THE QUAD MODULE BOARD IN AN ATTEMPT TO RESOLVE THE ISSUE. WHEN THE CUSTOMER POWERED THE I2000SR ANALYZER BACK ON THERE WAS A LOUD POPPING NOISE AND A FLASH OF WHITE LIGHT. THE REPLACEMENT RESISTOR BURNED AND A SMALL AMOUNT OF SMOKE WAS GENERATED. AN FSR REPLACED THE MALFUNCTIONING QUAD MODULE BOARD TO RESOLVE THE ISSUE. THE ARCHITECT ANALYZER HAS NOT GENERATED A BURNING SMELL OR VISIBLE SMOKE SINCE THE FSR REPLACED THE QUAD MODULE BOARD. BASED ON THE AVAILABLE INFORMATION AND THIS EVALUATION, NO DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000SR PROCESSING MODULE LIST NUMBER 03M74-01 FOR THE ISSUE UNDER EVALUATION. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ARCHITECT I2000SR ANALYZER TRIPS THE POWER SWITCH EACH TIME THEY TRY TO POWER ON THE ANALYZER. THE R1 RESISTOR ON THE QUAD MODULE BOARD HAD BLOWN AND WHEN REPLACED HAD BLOWN AGAIN. THIS TIME THE BLOWN FUSE WAS ACCOMPANIED BY A LOUD POPPING SOUND WITH A FLASH OF WHITE LIGHT WITH A SMALL AMOUNT OF SMOKE. THERE ARE NO REPORTS OF ANY INJURIES OR DAMAGE TO THE SURROUNDING ENVIRONMENT. A DEFECTIVE QUAD MODULE BOARD IS SUSPECTED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 BD QUAD MODULE LN:7-92696-01| BD QUAD MODULE LN:7-92696-01