BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3162447 · Received June 11, 2013

    Report

    Report Number
    2247117-2013-00054
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJQ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST REQUESTED ADDITIONAL INFORMATION, INSTRUMENT FILES AND DATA LOGS FROM THE CUSTOMER SITE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. THE CAUSE OF THE NON-LINEAR DILUTIONS FOR ESTRADIOL ON THREE PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (07/29/2013): A SIEMENS GLOBAL PRODUCT SUPPORT SPECIALIST (GPS) EVALUATED THE INSTRUMENT DATA . AFTER EVALUATING THE INSTRUMENT DATA THE GPS SPECIALIST DID NOT FIND ANY INSTRUMENT MALFUNCTION. A SIEMENS FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER SITE AND INSTRUCTED THE CUSTOMER TO CHANGE THE SAMPLE DILUENT ON THE INSTRUMENT. SINCE CHANGING THE SAMPLE DILUENT THE CUSTOMER HAS CONFIRMED WITH GPS THAT THERE HAVE BEEN NO DISCORDANT SAMPLES ON THE SYSTEM. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    NON-LINEAR DILUTION RESULTS FOR ESTRADIOL WERE OBTAINED ON THREE PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. THE THREE SAMPLES WERE RUN NEAT AND AT A 1:3 DILUTION. THE PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DILUTION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263042 IMMULITE 2000 IMMULITE 2000 JJQ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1