BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ANDROSTENEDIONE

    MDR report key: 4302170 · Received December 5, 2014

    Report

    Report Number
    2432235-2014-00690
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Date of Event
    August 27, 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
    NC, US
    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 MEDICAL DEVICE RECALL (UMDR) 2014-11-17 FOR IMMULITE/IMMULITE 1000 AND UMDR 2014-11-18 FOR IMMULITE 2000 WAS SENT TO US CUSTOMERS IN NOVEMBER OF 2014. THE UMDR 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 OBSERVED LOW BIAS ON THE RESTORED ANDROSTENEDIONE ASSAY COMPARED TO THE OLD ASSAY ON AN IMMULITE 2000 INSTRUMENT WHEN USING REAGENT LOT 332 AND 323. THE CUSTOMER CARRIED OUT A CORRELATION STUDY ON PATIENT SAMPLES AND COMPARED VALUES OBTAINED BETWEEN THE NEW AND OLD ANDROSTENEDIONE METHODS. IT IS UNKNOWN IF ANY RESULTS ARE BEING REPORTED TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES REPORTED DUE TO THE LOW BIAS OBSERVED ON THE PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787692 IMMULITE 2000 ANDROSTENEDIONE IMMULITE 2000 ANDROSTENEDIONE CIZ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED IMMULITE 1000 ANDROSTENEDIONE 323, 332

    Patients

    Seq Age Sex Outcome Treatment
    1 Other