BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1200904 · Received October 20, 2008

    Report

    Report Number
    1628664-2008-00237
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): UPS AND WASTE PIPE. REVIEW OF THE COMPLAINT TEXT INDICATES THE CUSTOMER REPORTED LEAKING FROM THE BACK OF THE INSTRUMENT ONTO THE FLOOR AND REQUESTED SERVICE. THE CUSTOMER ACKNOWLEDGED THE UNINTERRUPTIBLE POWER SUPPLY (UPS) BRIEFLY SPARKED AND EMITTED A SMOKING SMELL. THE CUSTOMER STATED NO INJURIES WERE SUSTAINED. THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND THE LEAK ORIGINATED FROM A CRACK IN THE END OF THE DRAIN MANIFOLD TUBE, P/N 78349-01, AT THE BACK OF THE INSTRUMENT. THE FSR REPORTED TO CUSTOMER SUPPORT THAT THE LEAK REACHED THE UPS PLUG AND CAUSED IT TO SHORT OUT. THE FSR REPLACED THE UPS AND THE DRAIN MANIFOLD AND VERIFIED NO LEAKS BY FLUSHING FLUIDS. HE ALSO RAN QC AND REPORTED THE INSTRUMENT MEETS SPECIFICATIONS. A REVIEW OF THE COMPLAINT HISTORY FOR ARCHITECT I SYSTEM SN (B)(4) OVER THE PERIOD OF TIME OF (B)(6) 2007 THROUGH (B)(6) 2009 WAS PERFORMED. THE REVIEW DID NOT FIND OTHER COMPLAINTS RELATED TO THIS ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL (PN (B)(4) MAY 2005) INDICATES THE FOLLOWING RELATED TO THE CUSTOMER ISSUE: SECTION 7: OPERATIONAL PRECAUTIONS AND LIMITATIONS. OPERATIONAL REQUIREMENTS, PRECAUTIONS, AND LIMITATIONS ARE PROVIDED TO ENSURE OPERATOR SAFETY AND ACCURATE ASSAY RESULTS. NOT FOLLOWING THESE REQUIREMENTS OR TAKING THESE PRECAUTIONS CAN IMPACT SYSTEM AND ASSAY PERFORMANCE AND MAY CAUSE DAMAGE TO THE SYSTEM OR ADVERSELY AFFECT ASSAY RESULTS. SECTION 8: ELECTRICAL HAZARDS INSTRUCTS THE OPERATOR TO INSPECT THE ELECTRICAL CABLING INTO AND ON THE ARCHITECT SYSTEM FOR SIGNS OF WEAR AND DAMAGE, TO KEEP LIQUIDS AWAY FROM ALL CONNECTORS OF ELECTRICAL OR COMMUNICATION COMPONENTS, AND TO KEEP THE FLOOR DRY AND CLEAN UNDER AND AROUND THE ARCHITECT SYSTEM. IT ALSO INSTRUCTS THE OPERATOR HOW TO HANDLE WASTE AND SPILL CLEAN UPS. A MALFUNCTION OF THE SYSTEM WAS NOT IDENTIFIED. THE INCIDENT WAS A RESULT OF THE LEAK FROM THE CRACK OF THE DRAIN MANIFOLD TOUCHING THE UPS. THIS IS THE FINAL REPORT.

    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.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT I2000K ANALYZER IS LEAKING (FROM THE BACK OF THE ANALYZER). THE ACCOUNT BELIEVES THE LEAK IS COMING FROM THE WASTE LINE CONNECTION. THE LEAK FROM THE ANALYZER CAME IN CONTACT WITH THE UPS ELECTRICAL PLUG ON THE FLOOR. THIS CAUSED A BRIEF SPARKING AND SMOKE CAUSING THE UPS CONNECTION TO SHORT OUT. THE CUSTOMER ALSO STATED THAT THERE WAS A BURNING ODOR. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI MANIFOLD WASTE ASSEMBLY, LIST #7-78349-01.| MANIFOLD WASTE ASSEMBLY, LIST #7-78349-01.