BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN

    MDR report key: 3212093 · Received July 8, 2013

    Report

    Report Number
    2432235-2013-00231
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 31, 2012
    Report Date
    June 13, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MTF
    PMA / PMN Number
    P930027
    Removal / Correction Number
    2432235-06/25/13-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS INVESTIGATED THE INCIDENCE OF POSITIVE BIAS ON IMMULITE 2000 PSA ASSAY, AND A POSITIVE BIAS OF 20-23 PERCENT RELATIVE TO WHO 96/670 HAS BEEN CONFIRMED. AN URGENT MEDICAL DEVICE RECALL (UMDR) - UMDR2013-06-25 IMMULITE/ IMMULITE 1000/ IMMULITE 2000/ IMMULITE 2000 XPI PSA POSITIVE BIAS TO WHO 96/670 - WAS SENT TO CUSTOMERS IN JUNE 2013. THE UMDR STATES THAT CUSTOMERS ARE TO DISCONTINUE USE OF THE PRODUCT AND DISCARD AFFECTED KITS REMAINING IN THEIR INVENTORY. THE CAUSE OF THE POSITIVE BIAS ON THE IMMULITE 2000 PSA ASSAY IS A CONTROL SYSTEM DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBSERVED HIGH BIAS ON QUALITY CONTROLS FOR THE IMMULITE PROSTATE SPECIFIC ANTIGEN ASSAY WHEN USING REAGENT LOT 104. THE ASSAY WAS RUN ON AN IMMULITE 2000 INSTRUMENT. QUALITY CONTROL LEVELS 2 AND 3 WERE OUTSIDE OF THE CUSTOMER'S EXPECTED RANGE. THE QUALITY CONTROL RESULTS WERE HIGH COMPARED TO REAGENT LOT 101, THE CUSTOMER'S PREVIOUS LOT. THE CUSTOMER RAN A PATIENT CORRELATION BETWEEN LOT 101 AND LOT 104 AND STATED THAT THERE WAS NO SIGNIFICANT SHIFT IN RESULTS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH BIAS ON THE QUALITY CONTROLS FOR THE PSA ASSAY WHEN USING REAGENT LOT 104.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309067 IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN MTF SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN 104

    Patients

    Seq Age Sex Outcome Treatment
    1