BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR FERRITIN (FER) ASSAY

    MDR report key: 3240930 · Received July 22, 2013

    Report

    Report Number
    1219913-2013-00152
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 23, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    DBF
    PMA / PMN Number
    K992157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT FERRITIN RESULTS IS UNKNOWN. THE HOOK EFFECT IS A POSSIBLE CAUSE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE HIGH DOSE HOOK EFFECT SECTION: "PATIENT SAMPLES WITH HIGH FERRITIN LEVELS CAN CAUSE A PARADOXICAL DECREASE IN THE RLUS (HIGH DOSE HOOK EFFECT). IN THIS ASSAY, PATIENT SAMPLES WITH FERRITIN LEVELS AS HIGH AS 80,000 NG/ML (176,000 PMOL/L) WILL ASSAY GREATER THAN 1650 NG/ML (3630 PMOL/L)." THE IFU STATES IN THE DILUTIONS SECTION: "SAMPLES WITH FERRITIN LEVELS GREATER THAN 1650 NG/ML (3630 PMOL/L) MUST BE DILUTED AND RETESTED TO OBTAIN ACCURATE RESULTS."

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR FERRITIN RESULTS WERE OBTAINED ON SIX SAMPLES FROM THE SAME PATIENT. PATIENT HISTORY IS HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH). THE PATIENT SAMPLES WERE TESTED WITHIN 6 DAYS AND WERE ALL FRESH DRAWS. REPEAT TESTING WAS PERFORMED ON THE SAMPLES AND THE RESULTS WERE ALL HIGH. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FERRITIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339891 ADVIA CENTAUR FERRITIN (FER) ASSAY FERRITIN IMMUNOASSAY DBF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 230

    Patients

    Seq Age Sex Outcome Treatment
    1