BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI ANDROSTENEDIONE

    MDR report key: 3756387 · Received April 17, 2014

    Report

    Report Number
    2432235-2014-00286
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 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
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00286 WAS FILED ON APRIL 17, 2014. THE FIRST FOLLOW UP MDR 2432235-2014-00286_S1 WAS FILED ON JUNE 11, 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) (B)(4) FOR IMMULITE/IMMULITE 1000 AND UFSN (B)(4) 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 2432235-2014-00286 WAS FILED ON APRIL 17, 2014. ADDITIONAL INFORMATION (5/27/14): THE OVER RECOVERY AND LOSS OF LINEARITY OF THE IMMULITE SYSTEMS ANDROSTENEDIONE ASSAY HAS BEEN IDENTIFIED TO BE VARIABILITY OF A CRITICAL RAW MATERIAL (VARIATION IN THE ACTIVITY OF RMA160 ALKALINE PHOSPHATASE (UNLABELED/LOW ACTIVITY ALKALINE PHOSPHATASE, COLD AP) IN THE REAGENT WEDGE). IN ADDITION, SIEMENS HEALTHCARE SENT OUT A CUSTOMER BULLETIN 2014-05 IN MAY 2014, ANNOUNCING THE RESTORATION OF THE LINEARITY OF THE ANDROSTENEDIONE ASSAY ON THE IMMULITE 2000/IMMULITE 2000 XPI TO 10 NG/ML (35 NML/L), BEGINNING WITH KIT LOT 331.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS INVESTIGATED THE INCIDENCE OF OVER RECOVERY OF PATIENT SAMPLES AND QUALITY CONTROLS ON THE IMMULITE/IMMULITE1000 ANDROSTENEDIONE ASSAY LOT NUMBER 409 AND ABOVE, AND IMMULITE 2000/IMMULITE 2000 XPI ANDROSTENEDIONE ASSAY LOT NUMBER 314 AND ABOVE. SIEMENS HAS CONFIRMED THAT THESE LOTS ARE LINEAR UP TO A CONCENTRATION OF 5.5 NG/ML, INSTEAD OF THE 10 NG/ML AS STATED IN THE INSTRUCTIONS FOR USE (IFU). QUALITY CONTROL MATERIALS AT CONCENTRATIONS BETWEEN 5.5 NG/ML AND 10 NG/ML WILL DETECT THIS ISSUE. AN URGENT MEDICAL DEVICE CORRECTION (UMDC) 2013-12-19 WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) 4008 WAS SENT TO OUS CUSTOMERS IN DECEMBER OF 2013. THE UMDC AND UFSN STATE THAT CUSTOMERS ARE REQUESTED TO USE QUALITY CONTROL MATERIALS WITH AT LEAST TWO LEVELS HAVING CONCENTRATIONS LESS THAN 5.5 NG/ML, AND THAT PATIENT VALUES >5.5 NG/ML SHOULD BE VERIFIED USING AN ALTERNATE METHOD.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBSERVED HIGH RESULTS ON THREE PATIENT SAMPLES FOR THE ANDROSTENEDIONE ASSAY ON AN IMMULITE 2000 INSTRUMENT. THE PATIENT SAMPLE VALUES DO NOT FIT THE CLINICAL PICTURE OF THE PATIENT, AS THE OTHER BIOMARKERS TESTED ON AN ALTERNATE PLATFORM ARE WITHIN NORMAL RANGE. THE PATIENT SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH RESULTS OBSERVED ON THE PATIENT SAMPLES FOR ANDROSTENEDIONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235040 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