BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ANDROSTENEDIONE

    MDR report key: 4294799 · Received December 3, 2014

    Report

    Report Number
    2432235-2014-00678
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    April 25, 2014
    Report Date
    November 14, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED
    Product Code
    CIZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2432235-11/20/14-005R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS OBSERVED OVER-RECOVERY IN THE IMMULITE/IMMULITE 1000/IMMULITE 2000 ANDROSTENEDIONE ASSAY FOR SAMPLES ACROSS THE ASSAYS' REPORTABLE RANGE OF 0.3-10 NG/ML (1.1-35 NMOL/L). SIEMENS HAS CONFIRMED THAT THE ISSUE NOTED IN THE DECEMBER 2013 FIELD ACTION IS NOT LIMITED TO ONLY SAMPLES >5.5 NG/ML (19.2 NMOL/L). SIEMENS HAS IDENTIFIED THAT THE ROOT CAUSE OF THE OVER-RECOVERY IS RELATED TO THE VARIABILITY OF A CRITICAL RAW MATERIAL. THIS ISSUE HAS BEEN RESOLVED BEGINNING WITH IMMULITE/IMMULITE 1000 KIT LOT 431, AND FOR IMMULITE 2000 BEGINNING WITH KIT LOT 331. AN URGENT FIELD SAFETY NOTICE (UFSN) 1113 FOR IMMULITE/IMMULITE 1000 AND UFSN 3021 FOR IMMULITE 2000 WAS SENT TO OUS CUSTOMERS IN NOVEMBER OF 2014. THE UFSN RECOMMENDS THAT THE CUSTOMER DISCARD THE AFFECTED KIT LOTS AND TO REVIEW THE LETTER WITH THEIR MEDICAL DIRECTOR.

    Description of Event or Problem · 1

    THE CUSTOMER HAS CONCERNS REGARDING THE DILUTION PROTOCOL FOR THE ANDROSTENEDIONE ASSAY ON THE IMMULITE 2000 INSTRUMENT WHEN USING REAGENT LOT 320. THE RESULTS OBTAINED ON THE DILUTED SAMPLE WAS NOT WHAT WAS EXPECTED. NINE PATIENT SAMPLES WERE FIRST RUN NEAT AND THEN DILUTED AND RUN AGAIN ON THE IMMULITE 2000 INSTRUMENT. THREE OF THE NINE SAMPLES WERE <5.5 NG/ML WHEN TESTED NEAT AND SHOWED AN OVER-RECOVERY WHEN DILUTED. THE RESULTS OBTAINED ON THE IMMULITE 2000 INSTRUMENT WERE NOT REPORTED TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE UNEXPECTED RESULTS FOR THE ANDROSTENEDIONE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781322 IMMULITE 2000 ANDROSTENEDIONE IMMULITE 2000 ANDROSTENEDIONE CIZ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED IMMULITE 2000 ANDROSTENEDIONE 320

    Patients

    Seq Age Sex Outcome Treatment
    1