BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ANDROSTENEDIONE

    MDR report key: 4294793 · Received December 3, 2014

    Report

    Report Number
    2432235-2014-00676
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    April 17, 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
    GM
    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 OBTAINED A HIGH RESULT ON ONE PATIENT SAMPLE FOR THE ANDROSTENEDIONE ASSAY ON THE IMMULITE 2000 INSTRUMENT WHEN USING REAGENT LOT 319 . THE SAMPLE WAS ALSO RUN ON AN ALTERNATE PLATFORM AND THE RESULT OBTAINED WAS LOWER WHEN COMPARED TO THE IMMULITE 2000 RESULT. A NEW BLOOD DRAW FROM THE SAME PATIENT WAS RUN AGAIN ON THE IMMULITE 2000 INSTRUMENT AND THE RESULT OBTAINED WAS ABOVE THE ASSAY RANGE. THE SAMPLE WAS DILUTED AND REPEATED ON THE IMMULITE 2000 INSTRUMENT. THE INITIAL RESULT OBTAINED ON THE IMMULITE 2000 INSTRUMENT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH RESULT OBTAINED FOR THE ANDROSTENEDIONE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781321 IMMULITE 2000 ANDROSTENEDIONE IMMULITE 2000 ANDROSTENEDIONE CIZ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED IMMULITE 2000 ANDROSTENEDIONE 319

    Patients

    Seq Age Sex Outcome Treatment
    1