BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4KSCORE TEST

    MDR report key: 16892723 · Received May 8, 2023

    Report

    Report Number
    3003652672-2022-00201
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    November 9, 2022
    Report Date
    May 7, 2023
    Manufacturer
    BIOREFERENCE HEALTH, LLC
    Product Code
    QRF
    PMA / PMN Number
    P190022
    Removal / Correction Number
    3003652672-04/12/2023-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ONE DEVICE MALFUNCTION IMPACTED 662 TEST RESULTS. PLEASE REFER TO SECTION H10 IN MANUFACTURER'S REPORT NO. 3003652672-2022-00001 FOR A COMPLETE DISCUSSION WITH RESPECT TO THE LATE FILING DATE AND DESCRIPTION OF THE DEVICE MALFUNCTION. PLEASE REFER TO THIS NOTED REPORT FOR ALL OTHER COMMON INFORMATION THAT IS NOT SPECIFIC TO THIS SUBJECT'S CASE.

    Description of Event or Problem · 0

    A 63-YEAR-OLD MALE WITH A HISTORY OF HIGH LEVEL OF PROSTATE SPECIFIC ANTIGEN (PSA), SUBMITTED A SAMPLE FOR 4KSCORE TEST ANALYSIS ON (B)(6) 2022, WHICH WAS CONDUCTED ON (B)(6)2022. THE SUBJECT'S UROLOGICAL HISTORY INCLUDED A PREVIOUS DIGITAL RECTAL EXAM WITH A PROSTATE NODULE PRESENT. THE SUBJECT DID NOT HAVE ANY PRIOR BIOPSY. HIS 4KSCORE WAS 15.2 AND THIS RESULT WAS REPORTED TO THE REQUISTIONER/PROVIDER ON (B)(6) 2022. GIVEN THE IDENTIFICATION OF THE INPUT ERROR IN THE SAMPLE REQUISITION INTAKE SOFTWARE, HIS 4KSCORE WAS RECALCULATED AND REPORTED TO THE PHYSICIAN ON (B)(6) 2022, WITH A REVISED 4KSCORE OF 23.6, EIGHT DAYS AFTER THE INITIAL RESULT REPORT. GIVEN THAT THE INITIAL 4KSCORE RESULT WAS < 20 , BUT INCREASED UPON RECALCULATION, IT IS POSSIBLE THAT THE SUBJECT MAY HAVE HAD A DELAY IN PROCEDURES TO DETERMINE HIS PROSTATE HEALTH. IT IS NOTED THAT A 4KSCORE VALUE OF 20 AND ABOVE INDICATES A HIGH PROBABILITY AND RISK OF FINDING HIGH GRADE PROSTATE CANCER SHOULD A BIOPSY BE PERFORMED. GIVEN THE SLOW NATURE OF PROSTATE CANCER GROWTH, A DELAYED DECISION IS EXPECTED TO HAVE MINIMAL CLINICAL SEQUELAE FOR THE PATIENT. HOWEVER, THE SUBJECT HAD NO CHANGE IN MANAGEMENT, OR INCREASED FOLLOW-UP WITH NO BIOPSY PERFORMED. TO DATE, NEITHER THE PMA HOLDER NOR THE MANUFACTURER HAS RECEIVED OR IS AWARE OF ANY UNTOWARD EVENTS/EFFECTS AS A RESULT OF THIS DEVICE MALFUNCTION AND ERRANT INITIAL 4KSCORE TEST RESULTS. THIS ONE DEVICE MALFUNCTION IMPACTED 662 TEST RESULTS. PLEASE REFER TO SECTION H10 IN MANUFACTURER'S REPORT NO. 3003652672-2022-00001 FOR A COMPLETE DISCUSSION WITH RESPECT TO THE LATE FILING DATE AND DESCRIPTION OF THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582688 4KSCORE TEST 4K QRF

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other