BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2810373 · Received October 31, 2012

    Report

    Report Number
    2247117-2012-00092
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE SIEMENS TECHNICAL SOLUTIONS CENTER AFTER OBTAINING DISCORDANT ANDROSTENEDIONE RESULTS ON PATIENT SAMPLES. THE OPERATOR HAD PERFORMED MANUAL DILUTIONS OF 1:2 AND 1:5 ON ONE PATIENT SAMPLE AFTER THE INSTRUMENT PRODUCED ERROR FLAGS WHEN THE SAMPLE WAS RUN NEAT. THE 1:2 AND 1:5 RESULTS DID NOT MATCH. THERE IS NO COMMERCIALLY AVAILABLE DILUENT FOR ANDROSTENEDIONE, AND THE OPERATOR USED A PATIENT SAMPLE THAT HAD RESULTED AS "ZERO" FOR THE DILUENT. HOWEVER, THE INSTRUCTIONS FOR USE FOR IMMULITE 2000 ANDROSTENEDIONE DOES NOT SUPPORT DILUTIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ANDROSTENEDIONE (ANDRO) RESULTS WERE OBTAINED ON DILUTED PATIENT SAMPLES ON THE IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ANDRO RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1