BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI ANDROSTENEDIONE

    MDR report key: 3740816 · Received April 10, 2014

    Report

    Report Number
    2432235-2014-00277
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    February 15, 2014
    Report Date
    March 17, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    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

    THE CAUSE OF THE HIGH BIAS OBSERVED ON THE PATIENT SAMPLES FOR ANDROSTENEDIONE IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00277 WAS FILED ON (B)(6) 2014. THE FIRST FOLLOW UP MDR 2432235-2014-00277_S1 WAS FILED ON (B)(6) 2014. ADDITIONAL INFORMATION (11/14/14): 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.

    Additional Manufacturer Narrative · 1

    THE ORIGINAL MDR 2432235-2014-00277 WAS FILED ON APRIL 10, 2014. ADDITIONAL INFORMATION (4/22/14): SIEMENS GLOBAL PRODUCT SUPPORT (GPS) RECEIVED INFORMATION FROM THE CUSTOMER REGARDING THE HIGH VALUES OBTAINED ON THE SEVEN PATIENT SAMPLES FOR ANDROSTENEDIONE ON THE IMMULITE 2000 INSTRUMENT. THE CUSTOMER INFORMED GPS THAT THEY ARE GOING TO USE THE ENHANCED ASSAY REFERENCE RANGE VALUES PROVIDED BY SIEMENS HEALTHCARE (CUSTOMER BULLETIN (B)(4)) IN OCTOBER OF 2011. BASED ON THE ENHANCED ASSAY REFERENCE RANGE THE SEVEN PATIENT SAMPLES STATED IN THE MDR FELL IN THE NORMAL RANGE OF THE ASSAY. THE CUSTOMER HAS INFORMED GPS THAT NO FURTHER ASSISTANCE IS NEEDED. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBSERVED HIGH BIAS ON SEVEN PATIENT SAMPLES FOR THE ANDROSTENEDIONE ASSAY ON AN IMMULITE 2000 INSTRUMENT. THE PATIENT SAMPLE VALUES FOR ANDROSTENEDIONE DID NOT CORRESPOND CLINICALLY TO VALUES OBTAINED ON OTHER HORMONAL MARKERS. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH BIAS OBSERVED ON THE PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217975 IMMULITE 2000 XPI ANDROSTENEDIONE IMMULITE 2000 XPI ANDROSTENEDIONE CIZ SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 XPI ANDROSTENEDIONE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1