BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 INTACT PTH

    MDR report key: 4200455 · Received October 24, 2014

    Report

    Report Number
    2432235-2014-00613
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEW
    PMA / PMN Number
    K013566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00613 WAS FILED ON OCTOBER 24, 2014. ADDITIONAL INFORMATION (11/12/2014): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST OBTAINED THE PATIENT SAMPLE AND PERFORMED AUTOMATIC DILUTIONS ON IT. THE DILUTIONS WERE PERFORMED AT 1:3, 1:5, 1:10 AND 1:20. THE RESULTS OBTAINED ON DILUTION INDICATED THAT THE CAUSE OF FALSE HIGH INTACT PARATHYROID HORMONE IS DUE TO INTERFERENCE.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE FALSELY HIGH IPTH RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSELY HIGH RESULTS ON SAMPLES FORM ONE PATIENT TESTED FOR INTACT PARATHYROID HORMONE (IPTH) ON AN IMMULITE 2000 INSTRUMENT USING REAGENT LOT 309. SAMPLE 1 WAS TESTED IN DUPLICATE ON THE IMMULITE 2000 SYSTEM AND RESULTED FALSELY HIGH. A NEW SAMPLE WAS DRAWN FROM THE PATIENT, WHICH ALSO RESULTED FALSELY HIGH ON THE SAME SYSTEM WITH THE SAME REAGENT LOT. BOTH SAMPLES WERE THEN TESTED ON AN ALTERNATE PLATFORM AND THE RESULTS WERE LOWER. IT IS UNKNOWN WHETHER THE FALSELY HIGH OR CORRECTED RESULTS WERE REPORTED TO PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE HIGH IPTH RESULTS ON THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678964 IMMULITE 2000 INTACT PTH IMMULITE 2000 INTACT PTH CEW SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 INTACT PTH 309

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR