BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 2920736 · Received January 17, 2013

    Report

    Report Number
    2247117-2013-00007
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 19, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CJZ
    PMA / PMN Number
    P010053/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE DETERMINED THAT THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED ALBUMIN RESULTS IS USER ERROR. THE OPERATOR RAN PATIENT SAMPLES WHILE THE ALBUMIN QUALITY CONTROLS WERE OUT OF RANGE HIGH. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED ALBUMIN RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. THE CUSTOMER RAN THE SAMPLES IN DUPLICATE WHILE PERFORMING A LOT-TO-LOT CORRELATION, AND THE RESULTS WERE LOWER THAN THE RESULTS OF THEIR INITIAL RUN. THE CUSTOMER DISCOVERED THAT THE QUALITY CONTROLS FOR ALBUMIN HAD BEEN OUT OF RANGE HIGH THE DAY OF THE DISCORDANT RESULTS. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE THEN RERUN IN DUPLICATE ON AN ALTERNATE INSTRUMENT TO CONFIRM THE CORRECT RESULTS. IT IS UNKNOWN IF CORRECTED REPORTS WERE SENT TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ALBUMIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25841 IMMULITE 2000 XPI IMMULITE 2000 XPI CJZ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1