BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM 6 CHANNEL ANALYZER

    MDR report key: 6307407 · Received February 7, 2017

    Report

    Report Number
    1415939-2017-00008
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 11, 2017
    Report Date
    November 1, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MZA
    PMA / PMN Number
    BK970042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES. THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE ABBOTT PRISM XY AXIS CONTROLLER ASSEMBLY, CATALOG NUMBER 1-51110-03, FAILED AT FIRST USE, EMITTING SMOKE FROM THE AREA OF THE X AXIS MOTOR BOARD WITHIN THE ASSEMBLY. THE PRISM INSTRUMENT (S/N (B)(4)) WAS POWERED OFF AND THE SMOKE DISSIPATED. THE X AXIS MOTOR BOARD WAS THEN REPLACED WITH A NEW X AXIS MOTOR BOARD. THE NEW X AXIS MOTOR BOARD ABBOTT PRISM XY GANTRY MOTOR CONTROLLER, CATALOG NUMBER 1-900445-01, ALSO FAILED AT FIRST USE EMITTING SMOKE. THE PRISM INSTRUMENT WAS POWERED OFF AGAIN AND THE SMOKE DISSIPATED. THE ISSUE WAS RESOLVED AT THE CUSTOMER SITE BY REPLACING THE ABBOTT PRISM XY AXIS CONTROLLER ASSEMBLY (1-51110-03). BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    A CORRECTION IN THE MANUFACTURERS REPORT NUMBER WAS NEEDED, THE MISTAKE WAS IDENTIFIED ON 1 NOVEMBER 2017.

    Description of Event or Problem · 1

    AN ABBOTT FIELD SERVICE ENGINEER STATED THAT UPON INSTALLING A NEW XY AXIS CONTROLLER ASSEMBLY ON PRISM ANALYZER SERIAL NUMBER (B)(4), A SMALL STREAM OF VISIBLE SMOKE WAS OBSERVED COMING FROM THE X AXIS MOTOR BOARD WITHIN THE XY CONTROLLER ASSEMBLY. THE PRISM WAS POWERED OFF. THE SMOKE WAS ISOLATED TO THE X AXIS MOTOR BOARD CARD CAGE AND DISSIPATED AFTER THE PRISM WAS POWERED OFF. THE ENGINEER REPLACED THE X AXIS MOTOR BOARD (PART 1-900445-01) BUT ONCE AGAIN A SMALL STREAM OF SMOKE WAS OBSERVED AND THE PRISM WAS POWERED OFF. NO FIRE WAS OBSERVED. NO INJURIES OCCURRED. THE ENGINEER REPLACED THE XY CONTROLLER ASSEMBLY TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92516 PRISM 6 CHANNEL ANALYZER AUTOMATED IMMUNOASSAY ANALYZER MZA ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1