BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN

    MDR report key: 3201353 · Received July 2, 2013

    Report

    Report Number
    2432235-2013-00247
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    November 21, 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

    SIEMENS HAS INVESTIGATED THE INCIDENCE OF POSITIVE BIAS ON IMMULITE 2000 PSA ASSAY, AND A POSITIVE BIAS OF (B)(4) PERCENT RELATIVE TO WHO(B)(4) HAS BEEN CONFIRMED. AN URGENT FIELD SAFETY NOTICE (UFSN) - (B)(4) IMMULITE/IMMULITE 2000/IMMULITE 2000 XPI PSA POSITIVE BIAS TO WHO (B)(4) - WAS SENT TO CUSTOMERS IN JUNE 2013. THE UFSN STATES THAT CUSTOMERS ARE TO DISCONTINUE USE OF THE PRODUCT AND DISCARD AFFECTED KITS REMAINING IN THEIR INVENTORY.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2013-00247 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.

    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 HIGH BIAS AFFECTED BIORAD CONTROLS AND PATIENT SAMPLE RESULTS. THE CUSTOMER RAN A PATIENT CORRELATION USING REAGENT LOT 379 AND A NEW REAGENT LOT. PATIENT 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 BIAS ON THE QUALITY CONTROLS FOR THE PSA ASSAY WHEN USING REAGENT LOT 379.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300524 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