BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTPACK IP SYSTEM - IN DOCTOR'S OFFICE ANALYZER FOR PSA VALUES

    MDR report key: 8164653 · Received December 13, 2018

    Report

    Report Number
    MW5082129
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    September 20, 2018
    Report Date
    December 3, 2018
    Manufacturer
    QUALIGEN, INC.
    Product Code
    LTJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    UROLOGIST TESTED ME FOR MY PSA, PROSTATE SPECIFIC ANTIGEN USING IN DOCTOR'S OFFICE, THE FAST PACK IP SYSTEM OFFICE ANALYZER FOR DETERMINING MY PSA VALUE. THIS IN OFFICE PSA TEST WAS PERFORMED, ONE ON THE SEPARATE OCCASIONS, 2 DIFFERENT UROLOGISTS AND 2 DIFFERENT FASTPACK ANALYZERS. IN ADDITION, I ALSO OBTAINED PSA VALUES USING OFF SITE LABS, USING MY VA AND OTHER HEALTH INSURANCE. THE PSA RESULTS ARE IN BLOCK 5 OF THIS FORM. DURING THE FIRST ROUND OF TESTING, THE FASTPACK IP PSA RESULTS WERE ALMOST DOUBLE THE 2 TRADITIONAL LAB RESULTS. DURING THE SECOND ROUND OF TEST RESULTS, THE FASTPACK IP RESULTS WERE AGAIN VERY HIGH COMPARED TO THE TRADITIONAL LAB RESULTS FOR PSA. POSSIBLE INFLATED PSA VALUES MAY LEAD TO INAPPROPRIATE TREATMENTS FOR LOW RISK PROSTATE CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998308 FASTPACK IP SYSTEM - IN DOCTOR'S OFFICE ANALYZER FOR PSA VALUES PROSTATE - SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS LTJ QUALIGEN, INC.
    998309 FASTPACK IP SYSTEM - IN DOCTOR'S OFFICE ANALYZER FOR PSA VALUES PROSTATE - SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS LTJ QUALIGEN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR