BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN

    MDR report key: 3180651 · Received June 20, 2013

    Report

    Report Number
    2432235-2013-00280
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 1, 2013
    Report Date
    January 15, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MTF
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE HIGH BIAS OBSERVED ON THE SIXTEEN PATIENT SAMPLE ON THE IMMULITE 2000 INSTRUMENT USING REAGENT LOT 383 COMPARED TO THE ALTERNATE PLATFORM IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER CONDUCTED A METHOD COMPARISON STUDY FOR PROSTATE SPECIFIC ANTIGEN (PSA) ON SIXTEEN PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT AND AN ALTERNATE PLATFORM. THE CUSTOMER OBSERVED A HIGH BIAS ON PATIENT SAMPLE RESULTS FOR PSA USING REAGENT LOT 383 RUN ON THE IMMULITE 2000 INSTRUMENT COMPARED TO AN ALTERNATE PLATFORM. ALL SAMPLES WERE NOT RUN ON THE INSTRUMENTS ON THE SAME DAY. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH BIAS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279834 IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN MTF SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN 383

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown