BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN

    MDR report key: 3201488 · Received July 2, 2013

    Report

    Report Number
    2432235-2013-00255
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    January 4, 2013
    Report Date
    June 13, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    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
    US
    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 MEDICAL DEVICE RECALL (UMDR) - (B)(4) IMMULITE/IMMULITE 2000/IMMULITE 2000 XPI PSA POSITIVE BIAS TO WHO (B)(4) - 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.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2013-00255 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 PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY WHEN USING REAGENT LOT 104. THE ASSAY WAS RUN ON AN IMMULITE 1000 INSTRUMENT, AND THE HIGH BIAS AFFECTED FOUR PATIENT SAMPLE RESULTS. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAMPLES WERE ALSO RUN ON AN ALTERNATE PLATFORM WHERE THE RESULTS WERE LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH BIAS ON THE PSA ASSAY WHEN USING REAGENT LOT 104.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301692 IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN MTF SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN 104

    Patients

    Seq Age Sex Outcome Treatment
    1