BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3181611 · Received June 21, 2013

    Report

    Report Number
    2247117-2013-00055
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 13, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LTK
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT THE FSE DISCOVERED THE VACUUM PUMP TO BE DEFECTIVE AND THE DUAL RESOLUTION DILUTOR (DRD) HAD TO BE READJUSTED. THE VACUUM PUMP WAS REPLACED AND THE DRD WAS ADJUSTED AT THE MIDDLE POSITION. THE FSE RAN QUALITY CONTROLS, ALL OF WHICH WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT CA-125 RESULT WAS DUE TO THE DEFECTIVE VACUUM PUMP AND THE DRD. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW CA 125 RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT ON (B)(6) 2013. THE PATIENT SAMPLE RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT ON (B)(6) 2013 AND THE RESULT WAS HIGHER. THE RESULT OF THE REPEATED SAMPLE WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282291 IMMULITE 2000 IMMULITE 2000 LTK SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1