BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2132641 · Received June 17, 2011

    Report

    Report Number
    1823260-2011-03318
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MTF
    PMA / PMN Number
    P990056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER ASSAYS RELATED TO THIS EVENT ARE REPORTED IN MEDWATCH REPORTS PATIENT IDENTIFIERS: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY WERE RECEIVING QUESTIONABLE RESULTS FOR TOTAL PSA (TPSA) ON THEIR MODULAR ANALYTICS E-MODULE (SERIAL NUMBER (B)(4)). THE CUSTOMER PROVIDED DATA FOR 17 SAMPLES OF WHICH THERE WERE TWO WITH DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. A PHYSICIAN QUESTIONED ONE OF THE PSA RESULTS AND THE CUSTOMER REPEAT ALL THE TPSA TESTS PERFORMED THAT DAY. REPEAT TESTING WAS PERFORMED ON THE SAME E- MODULE AND ISSUED AS A CORRECTED REPORT. THE FIRST PATIENT'S INITIAL TPSA RESULT WAS 1.16 NG/ML. THE REPEAT RESULT WAS 7.90 NG/ML. THE SECOND PATIENT'S INITIAL TPSA RESULT WAS 54.91 NG/ML. THE FIRST REPEAT RESULT WAS 100.0 NG/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED AND REPEATED THE SECOND REPEAT RESULT FROM THE ANALYZER WAS 483.3 NG/ML ACCOMPANIED BY A DATA FLAG. THE CUSTOMER WAS NOT AWARE OF ANY ADVERSE AFFECTS TO THE PATIENTS AS A RESULT OF THIS EVENT. THE CUSTOMER REFUSED A SERVICE VISIT. THE CUSTOMER RESOLVED THE ISSUE BY TROUBLESHOOTING THE ANALYZER. THEY PERFORMED LIQUID FLOW CLEANING THREE TIMES AND MEASURING CELL PREPARATION TWENTY TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTAT MTF ROCHE DIAGNOSTICS NA 16144001

    Patients

    Seq Age Sex Outcome Treatment
    1