BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)

    MDR report key: 2082954 · Received May 10, 2011

    Report

    Report Number
    1823260-2011-02470
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 5, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MTF
    PMA / PMN Number
    P990056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER ASSAY RELATED TO THIS EVENT IS REPORTED IN MEDWATCH REPORT WITH A1 PATIENT IDENTIFIER: (B)(6). THIS EVENT OCCURED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. THE VALUES THE CUSTOMER RECEIVED WERE VERIFIED. ALTHOUGH A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED, BASED UPON TESTING PERFORMED, THE RESULTS COULD BE EXPLAINED BY THE PRESENCE OF (B)(6) IN THE PATIENT SAMPLE BLOCKING AN EPITOPE ON (B)(6) OR (B)(6) IN THE PATIENT SAMPLE NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY WERE RECEIVING TOTAL PSA RESULTS THAT WERE LOWER THAN THE FREE PSA RESULTS ON THEIR ELECSYS 2010 RACK ANALYZER (SERIAL NUMBER (B)(4)). THERE WERE TWO DISCREPANT TEST RESULTS FROM THE SAME PATIENT TAKEN SIX DAYS APART. ALL RESULTS WERE FROM THE SAME ANALYZER. THE FIRST SAMPLE HAD A TOTAL PSA RESULT OF 0.497 NG/ML AND A FREE PSA RESULT OF 7.65 NG/ML. THE SECOND SAMPLE, FROM (B)(6) 2011, HAD A TOTAL PSA RESULT 0.513 NG/ML AND A FREE PSA RESULT 7.16 NG/ML. THERE WAS NO ALLEGATION OF ANY ADVERSE AFFECT TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTAT MTF ROCHE DIAGNOSTICS NA 159624

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR