BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN

    MDR report key: 3201352 · Received July 2, 2013

    Report

    Report Number
    2432235-2013-00246
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    November 1, 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
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2013-00246 WAS FILED ON JULY 2, 2013. ADDITIONAL INFORMATION (07/03/2013): THE CAUSE OF THE POSITIVE BIAS ON THE IMMULITE 2000 PSA ASSAY IS A CONTROL SYSTEM DEFICIENCY.

    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 FIELD SAFETY NOTICE (UFSN) - UFSN 4006 IMMULITE/IMMULITE 2000/IMMULITE 2000 XPI PSA POSITIVE BIAS TO WHO 96/670 - WAS SENT TO CUSTOMERS IN (B)(4) 2013. THE UFSN STATES THAT CUSTOMERS ARE TO DISCONTINUE USE OF THE PRODUCT AND DISCARD AFFECTED KITS REMAINING IN THEIR INVENTORY.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBSERVED HIGH BIAS FOR THE IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN (PSA) WHEN USING REAGENT LOT 379. THE ASSAY WAS RUN ON AN IMMULITE 2000 INSTRUMENT, AND THE HIGH BIAS AFFECTED BIORAD QUALITY CONTROLS. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH BIAS ON THE BIORAD QUALITY CONTROLS FOR THE PSA ASSAY WHEN USING REAGENT LOT 379.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301523 IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN MTF SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN 379

    Patients

    Seq Age Sex Outcome Treatment
    1