BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2902247 · Received January 8, 2013

    Report

    Report Number
    2247117-2013-00003
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED AIR BUBBLES IN THE SAMPLE, REAGENT, AND WATER PROBE TUBING. THE FSE PROACTIVELY REPLACED THE DIGITAL FLUIDICS PRINTED CIRCUIT BOARD AND THE SAMPLE MANIFOLD. THE FSE THEN PRIMED THE SYSTEM AND RAN TEN REPLICATES OF QUALITY CONTROLS, ALL OF WHICH WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT PTS RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT PROSTATE SPECIFIC ANTIGEN (PTS) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE IMMULITE 2000 INSTRUMENT. THE SAMPLES WERE RUN IN DUPLICATE, AND THE RESULTS DID NOT MATCH. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN FOLLOWING A SERVICE VISIT, AND THE CORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR UNNECESSARY TREATMENT DUE TO THE DISCORDANT PTS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9286 IMMULITE 2000 IMMULITE 2000 JJE SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1