BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 4532794 · Received February 20, 2015

    Report

    Report Number
    2247117-2015-00006
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Date of Event
    November 21, 2015
    Report Date
    January 26, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JLX
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INSTRUMENT DATA. THE CAUSE OF DISCORDANT PROGESTERONE RESULTS ON FOURTEEN PATIENT SAMPLES IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2247117-2015-00006 WAS FILED ON FEBRUARY 20, 2015. ADDITIONAL INFORMATION (04/21/2015): THE FALSELY LOW PROGESTERONE RESULTS OBSERVED BY THE CUSTOMER WAS INVESTIGATED AND IT WAS DETERMINED THAT THE SAMPLE COLLECTION TUBE TYPE WAS IMPACTING THE PROGESTERONE RESULTS. THE CUSTOMER WAS USING GEL BARRIER TUBES, WHICH IS AN OFF-LABEL USE. THE IMMULITE 2000 PROGESTERONE INSTRUCTIONS FOR USE STATES THAT "TIME-DEPENDENT DECREASES IN PROGESTERONE LEVELS HAVE BEEN REPORTED WHEN SERUM SAMPLES ARE COLLECTED AND STORED IN GEL BARRIER TUBES". THE CUSTOMER PERFORMED PROFICIENCY TESTING USING AN ALTERNATE SAMPLE COLLECTION TUBE TYPE, WHICH WAS ACCEPTABLE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST PROACTIVELY TIGHTENED THE DUAL RESOLUTION DILUTOR (DRD) NUT AND REPLACED THE REAGENT AND THE SAMPLE PROBES. THE INSTRUMENT IS PERFORMING ACCORDING TO THE SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT PROGESTERONE (PRG) RESULTS WERE OBTAINED ON FOURTEEN PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING HIGHER THAN THE INITIAL RESULTS EXCEPT FOR PATIENT 88138, WHICH RESULTED LOWER. THE REPEAT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121427 IMMULITE 2000 IMMULITE 2000 JLX SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1