BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3869978 · Received June 12, 2014

    Report

    Report Number
    1823260-2014-04304
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    November 11, 2011
    Report Date
    June 25, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LTJ
    PMA / PMN Number
    P990056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME PATIENT AS WAS PREVIOUSLY REPORTED IN MEDWATCHES 1823260-2013-03521-00 AND 1823260-2013-07606-00. THIS PATIENT IS KNOWN TO HAVE THE PRESENCE OF AN INTERFERING SUBSTANCE, SUCH AS AN ANTI-IDIOTYPE OR AUTO-ANTIBODY. THIS INTERFERENCE IS COVERED IN THE PRODUCT LABELING. OTHER REAGENT(S) INVOLVED IN THE COMPLAINT: BRAND NAME: FT3 - ELECSYS FREE PSA II. COMMON DEVICE NAME: TEST, PROSTATE SPECIFIC ANTIGEN,FREE, (NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS. MANUFACTURER INFORMATION: SAME AS FOR TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA). CATALOG NUMBER: 03289788190, LOT NUMBER: ASKU, EXPIRATION DATE: ASKU. MANUFACTURING SITE: SAME AS FOR TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA). PMA/510(K)#: P000027.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA) AND FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) RESULTS FOR ONE PATIENT ON THEIR E-MODULE. THE CUSTOMER STATED THIS HAD BEEN GOING ONE SINCE 2011. THE PATIENT PROVIDED DATA FOR TWO SAMPLES WITH DISCREPANT RESULTS. THE TPSA RESULT WAS 3.46 NG/ML AND THE FPSA RESULT WAS 5.54 NG/ML. THE SAMPLE WAS THEN TESTED ON A TANDEM METHOD. THE TPSA RESULT WAS 7.42 NG/ML AND FPSA RESULT WAS 2.86 NG/ML. THE PATIENT HAD ANOTHER SAMPLE TESTED. THE DATE OF THIS TEST WAS REQUESTED BUT NOT PROVIDED. THE TPSA RESULT WAS 3.180 NG/ML AND FPSA RESULT WAS 4.74 NG/ML. INFORMATION ON WHETHER THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE TPSA AND FPSA REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348512 TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS LTJ ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1