BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 3000402 · Received March 12, 2013

    Report

    Report Number
    2247117-2013-00027
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 13, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LTJ
    PMA / PMN Number
    P010053/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST EVALUATED THE INSTRUMENT DATA. AFTER EVALUATING THE INSTRUMENT DATA, THE GPS SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CAUSE OF THE DISCORDANT, FALSELY LOW PSA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW PROSTATE SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). A NEW SAMPLE FROM THE PATIENT WAS RECEIVED BY THE LABORATORY APPROXIMATELY ONE MONTH LATER, AND RESULTED HIGHER. THE LABORATORY RERAN THE INITIAL SAMPLE, AND THE RERUN RESULT WAS HIGHER THAN THE INITIAL RESULT REPORTED. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PSA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104055 IMMULITE 2000 XPI IMMULITE 2000 XPI LTJ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1