BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 2884712 · Received December 24, 2012

    Report

    Report Number
    1628664-2012-00511
    Event Type
    Malfunction
    Date Received
    December 24, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS INSPECTED BY AN ABBOTT SERVICE WHICH FOUND THAT THE PRESSURE MONITOR LEAKED ONTO A CABLE CONNECTION, CAUSING THE PRESSURE SENSOR CABLE TO SMOKE. A SEARCH OF THE SERVICE HISTORY FOR THE INSTRUMENT FOUND NO OTHER TICKETS RELATED TO THE COMPLAINT UNDER INVESTIGATION. NO ADVERSE OR NON-STATISTICAL TRENDS FOR THE PRESSURE SENSOR CABLE WERE IDENTIFIED. THE ARCHITECT C4000 SYSTEM SERVICE AND SUPPORT MANUAL HAS ADEQUATE INFORMATION FOR TROUBLESHOOTING, REMOVAL, AND REPLACEMENT OF THE PRESSURE SENSOR CABLE. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED RELATED TO THE MALFUNCTION REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER GOT SEVERAL ERRORS GENERATED BY THE ARCHITECT ANALYZER BEFORE OBSERVING SMOKE COMING OUT FROM THE BACK OF THE ANALYZER. THE CUSTOMER POWERED OFF THE ANALYZER AND BELIEVED THE PRESSURE MONITOR LEAKED ONTO CABLE CONNECTION AND CAUSED THE VISIBLE SMOKE. NO INJURIES WERE REPORTED AND NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C4000 ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1